Propofol Induced HypotensionNCT02845921

Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension

A study testing leg elevation and leg wrapping in people with Propofol Induced Hypotension, run by Nitte University at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Propofol is an intravenous anaesthetic agent used for both induction and maintenance of anaesthesia. An important adverse effect is the significant fall in blood pressure. The current clinical study will be done to determine the efficacy of leg elevation and wrapping in reducing the incidence and severity of propofol… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Propofol Induced Hypotension
What is being tested?: leg elevation and leg wrapping
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteIndia
Study dates: Jan 2016to Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients belonging to ASA physical status I and II undergoing endotracheal general anaesthesia

Who cannot join

Patient refusal
Contraindication to application of bandage
Partial or complete limb amputation
Difficult airway
Use of extraglottic airway device
Pregnancy
On antihypertensive or vasoactive medication
Autonomic neuropathy

Trial locations and contacts

1 site in 1 country.

Sara Jaison, MBBS contact

09846863119

sara_jaison@yahoo.co.in

Sripada G Mehandale, MBBS, MD contact

09448384310

dr_sgmehandale@rediffmail.com

India1 site, 1 recruiting

Justice K. S. Hegde Hospital, K S Hegde Medical Academy, Nitte University
Mangalore, Dakshina Kannada, 575018
Sara Jaison, MBBS, 09900632065, sara_jaison@yahoo.co.in
Sripada G Mehandale, MBBS, MD, 09448384310, dr_sgmehandale@rediffmail.com
Recruiting

Other trials in India

About this study

Official title: Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension: A Prospective Randomised Controlled Study

Read the detailed description

Propofol is an intravenous anaesthetic agent used for both induction and maintenance of anaesthesia. It is widely employed due to its quick onset of action, short half life and rapid recovery. An important adverse effect is the significant fall in blood pressure. Although the exact mechanism of propofol induced hypotension is not known, venodilation, decreased peripheral resistance and decrease in cardiac output has been suggested.2 Though the hypotension is transient, it can produce devastating effects. Hence there is a need to prevent it. Moreover, several attempts at treating propofol induced hypotension have been met with variable and limited success.

Hypotension following spinal anaesthesia is also a frequent problem. It is generally treated with intravenous fluids and vasopressors. Simple and non pharmacological measures like leg elevation and leg wrapping with Esmarch bandage were reported to be successful.3 These reduce the incidence and severity of hypotension associated with spinal anaesthesia by improving the venous return.

The mechanisms of hypotension following intravenous propofol and spinal anaesthesia are almost similar. Therefore, the investigators hypothesize that leg elevation and wrapping can be attempted to reduce propofol induced hypotension. They are simple and cost effective techniques that will reduce the need for pharmacological measures to control hypotension. As the literature search did not reveal any information regarding the usefulness of these techniques in propofol induced hypotension, the current clinical study will be done to determine the efficacy of leg elevation and wrapping in reducing the incidence and severity of propofol induced hypotension in patients undergoing general anaesthesia.

The current study will compare the efficacy of leg elevation and leg wrapping in reducing the incidence and severity of propofol induced hypotension in terms of incidence of hypotension, magnitude of decrease in systolic, diastolic and mean arterial blood pressures, need for pharmacological measures to treat hypotension, changes in heart rate and adverse clinical outcomes, if any. It will be a prospective randomised controlled open label study from January 2016 to August 2017 involving 150 adult patients undergoing general anaesthesia.

For statistical analysis, descriptive statistics - minimum, maximum, mean and standard deviation will be used. Independent sample t test for data following normal distribution and for data not following normal distribution, Mann-Whitney U test will be used. P value less than 0.05 will be considered statistically significant. To study relationship between hypotension and other variables, Pearson's correlation will be used. Confidence interval will be calculated to 95%.

Conditions: Propofol Induced Hypotension
Being tested: leg elevation, leg wrapping, control
Keywords: Propofol, Hypotension, Induction of anaesthesia, Leg elevation, Leg wrapping
Medical subject headings: Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

leg elevationOther
A stand making an angle of 30 degree to the horizontal is used to elevate both the legs
leg wrappingOther
Esmarch bandage is used to wrap each lower limb
controlOther
no intervention has been done

Study groups in NCT02845921
Study group	Role	What they receive
Group C Control	Placebo comparator	Patient will be shifted to operation theatre. Electrocardiography (ECG), pulse oximeter and non-invasive blood pressure (NIBP) monitors will be attached. Baseline vitals will be noted. Intravenous access will be secured and crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be neither elevated or wrapped. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Receives: Other: control
Group E Leg elevation	Experimental	Patient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs are elevated and supported on a stand making an angle of 30 degree to the horizontal. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Stand will be removed and legs will be brought to horizontal position 10 minutes after intubation. Receives: Other: leg elevation
Group W Leg wrapping	Experimental	Patient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl. Each lower limb will be elevated alternately and wrapped from toe to mid-thigh with Esmarch bandage. Care will be taken to avoid compressing the legs to greater than arterial pressure by confirming the presence of pulse using a saturation probe. Following wrapping, the lower limbs will be brought to horizontal position. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol injected over 30 seconds. Muscle relaxation by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Esmarch bandage will be removed 10 minutes after intubation. Receives: Other: leg wrapping

What is being measured

The primary outcome is the main question the study is designed to answer.

incidence of hypotension at baseline
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: baseline
incidence of hypotension at 0 minutes after leg elevation or wrapping
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 0 minutes after leg elevation or wrapping
incidence of hypotension at 0 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 0 minutes after induction with propofol
incidence of hypotension at 1 minute after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 1 minute after induction
incidence of hypotension at 2 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 2 minutes after induction
incidence of hypotension at 3 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 3 minutes after induction
incidence of hypotension at 4 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 4 minutes after induction
incidence of hypotension at 5 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 5 minutes after induction
incidence of hypotension at 0 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 0 minutes after intubation
incidence of hypotension at 1 minute after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 1 minute after intubation
incidence of hypotension at 2 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 2 minutes after intubation
incidence of hypotension at 3 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 3 minutes after intubation
incidence of hypotension at 4 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 4 minutes after intubation
incidence of hypotension at 5 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 5 minutes after intubation
incidence of hypotension at 6 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 6 minutes after intubation
incidence of hypotension at 7 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 7 minutes after intubation
incidence of hypotension at 8 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 8 minutes after intubation
incidence of hypotension at 9 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 9 minutes after intubation
incidence of hypotension at 10 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
Measured: 10 minutes after intubation

Secondary outcomes (71)

Magnitude of change in systolic blood pressure from baseline at 0 minutes after leg leg elevation or wrapping
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, after leg elevation or wrapping
Magnitude of change in systolic blood pressure from baseline at 0 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 0 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 1 minute after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 1 minute after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 2 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 2 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 3 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 3 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 4 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 4 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 5 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 5 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 0 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 0 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 1 minute after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 1 minute after intubation
Magnitude of change in systolic blood pressure from baseline at 2 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 2 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 3 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 3 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 4 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 4 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 5 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 5 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 6 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 6 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 7 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 7 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 8 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 8 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 9 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 9 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 10 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline systolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Systolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Systolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Systolic blood pressure will be recorded every minute till 10 min post intubation. Magnitude of change in systolic blood pressure from baseline will be noted
Measured: baseline, at 10 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 0 minutes after leg elevation or wrapping
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 0 minutes after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
Magnitude of change in diastolic blood pressure from baseline at 0 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 0 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 1 minute after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 1 minute after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 2 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 2 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 3 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 3 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 4 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 4 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 5 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 5 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 0 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 0 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 1 minute after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 1 minute after intubation
Magnitude of change in diastolic blood pressure from baseline at 2 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 2 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 3 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 3 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 4 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 4 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 5 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 5 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 6 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 6 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 7 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 7 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 8 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 8 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 9 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 9 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 10 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline diastolic blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Diastolic blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Diastolic blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in diastolic blood pressure from baseline will be noted.
Measured: baseline, at 10 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 0 minutes after leg elevation or wrapping
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 0 minutes after leg elevation or wrapping
Magnitude of change in mean arterial blood pressure from baseline at 1 minute after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 0 minute after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 2 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 2 minutes after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 3 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 3 minutes after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 4 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 4 minutes after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 5 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 5 minutes after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 0 minute after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 0 minute after intubation
Magnitude of change in mean arterial blood pressure from baseline at 1 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 1 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 2 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 2 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 3 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 3 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 4 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 4 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 5 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 5 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 6 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 6 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 7 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 7 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 8 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 8 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 9 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 9 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 10 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline mean arterial blood pressure will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Mean arterial blood pressure will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Mean arterial blood pressure will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Magnitude of change in mean arterial blood pressure from baseline will be noted
Measured: baseline, 10 minutes after intubation
changes in heart rate from baseline at 0 minutes after leg elevation or wrapping
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 0 minutes after leg elevation or wrapping
changes in heart rate from baseline at 0 minutes after induction with propofol
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 0 minute after induction with propofol
changes in heart rate from baseline at 1 minutes after induction with propofol
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 1 minutes after induction with propofol
changes in heart rate from baseline at 2 minutes after induction with propofol
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 2 minutes after induction with propofol
changes in heart rate from baseline at 3 minutes after induction with propofol
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 3 minutes after induction with propofol
changes in heart rate from baseline at 4 minutes after induction with propofol
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 4 minutes after induction with propofol
changes in heart rate from baseline at 5 minutes after induction with propofol
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 5 minutes after induction with propofol
changes in heart rate from baseline at 0 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 0 minutes after intubation
changes in heart rate from baseline at 1 minute after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 1 minute after intubation
changes in heart rate from baseline at 2 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 2 minutes after intubation
changes in heart rate from baseline at 3 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 3 minutes after intubation
changes in heart rate from baseline at 4 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 4 minutes after intubation
changes in heart rate from baseline at 5 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 5 minutes after intubation
changes in heart rate from baseline at 6 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 6 minutes after intubation
changes in heart rate from baseline at 7 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 7 minutes after intubation
changes in heart rate from baseline at 8 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 8 minutes after intubation
changes in heart rate from baseline at 9 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 9 minutes after intubation
changes in heart rate from baseline at 10 minutes after intubation
Patient will be shifted to operation theatre. Baseline heart rate will be noted. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be elevated, wrapped or none according to group allocation. Heart rate will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Heart rate will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Heart rate will be recorded every minute till 10 min post intubation. Changes in heart rate from baseline will be noted
Measured: baseline, 10 minutes after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Dec 2017

First posted27 Jul 2016 (estimated)
Study startJan 2016
Primary completionAug 2017 (estimated)
Study completionDec 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Propofol Induced HypotensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02845921
Sponsor's protocol ID: INST.EC/EC/066/2015-16
Status last verified: Jul 2016
First submitted: 30 Jun 2016
Last updated: 27 Jul 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Age, sex, weight, diagnosis, surgery, asa physical status, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure

Publications

McNeir DA, Mainous EG, Trieger N. Propofol as an intravenous agent in general anesthesia and conscious sedation. Anesth Prog. 1988 Jul-Aug;35(4):147-51.
PubMed 3046442
Muzi M, Berens RA, Kampine JP, Ebert TJ. Venodilation contributes to propofol-mediated hypotension in humans. Anesth Analg. 1992 Jun;74(6):877-83. doi: 10.1213/00000539-199206000-00017.
PubMed 1595920
Rout CC, Rocke DA, Gouws E. Leg elevation and wrapping in the prevention of hypotension following spinal anaesthesia for elective caesarean section. Anaesthesia. 1993 Apr;48(4):304-8. doi: 10.1111/j.1365-2044.1993.tb06948.x.
PubMed 8494130
Masoudifar M, Beheshtian E. Comparison of cardiovascular response to laryngoscopy and tracheal intubation after induction of anesthesia by Propofol and Etomidate. J Res Med Sci. 2013 Oct;18(10):870-4.
PubMed 24497858
Moller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate: a double-blind, randomized, clinical trial. Br J Anaesth. 2013 Mar;110(3):388-96. doi: 10.1093/bja/aes416. Epub 2012 Nov 19.
PubMed 23166149
Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
PubMed 16115962
Singh K, Payal YS, Sharma JP, Nautiyal R. Evaluation of hemodynamic changes after leg wrapping in elective cesarean section under spinal anesthesia. J Obstet Anaesth Crit Care. 2014;4:23-8

Want to know more?

Sara Jaison, MBBS

09846863119

sara_jaison@yahoo.co.in

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
Intraoperative Hypotension, Jugular Veins
Not yet recruiting
Propofol vs. Ciprofol for Anesthesia Induction in Frail Elderly Patients
Hypotension
Not yet recruiting
Comparison of Two Sedative Agents in Terms of Controlled Hypotension
Controlled Hypotension for Nasal Surgeries
RecruitingPhase 3
Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room
Rapid Sequence Induction
Recruiting
Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension
Magnesium Sulfate, Remifentanil

All Propofol Induced Hypotension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Leg Elevation and Leg Wrapping in the Prevention of Propofol Induced Hypotension: A Prospective Randomised Controlled Study
ClinicalTrials.gov ID: NCT02845921
Acronym / sponsor ID: INST.EC/EC/066/2015-16
Conditions: Propofol Induced Hypotension
Keywords: Propofol, Hypotension, Induction of anaesthesia, Leg elevation, Leg wrapping
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Nitte UniversityUniversity, hospital or other
Study start: Jan 2016
Primary completion: Aug 2017 (estimated)
Study completion: Dec 2017 (estimated)
First posted: 27 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group C Control	Placebo comparator	Other: controlPatient will be shifted to operation theatre. Electrocardiography (ECG), pulse oximeter and non-invasive blood pressure (NIBP) monitors will be attached. Baseline vitals will be noted. Intravenous access will be secured and crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs will be neither elevated or wrapped. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube.
Group E Leg elevation	Experimental	Other: leg elevationPatient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl 2µg/kg body weight. Lower limbs are elevated and supported on a stand making an angle of 30 degree to the horizontal. Vitals will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Muscle relaxation will be achieved by inj. vecuronium 0.1mg/kg body weight. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Stand will be removed and legs will be brought to horizontal position 10 minutes after intubation.
Group W Leg wrapping	Experimental	Other: leg wrappingPatient will be shifted to operation theatre. Crystalloids at 100ml/hr will be given. Analgesia will be given by inj fentanyl. Each lower limb will be elevated alternately and wrapped from toe to mid-thigh with Esmarch bandage. Care will be taken to avoid compressing the legs to greater than arterial pressure by confirming the presence of pulse using a saturation probe. Following wrapping, the lower limbs will be brought to horizontal position. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol injected over 30 seconds. Muscle relaxation by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Esmarch bandage will be removed 10 minutes after intubation.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients belonging to ASA physical status I and II undergoing endotracheal general anaesthesia

Key exclusion criteria (8 listed)

Patient refusal
Contraindication to application of bandage
Partial or complete limb amputation
Difficult airway
Use of extraglottic airway device

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
leg elevationA stand making an angle of 30 degree to the horizontal is used to elevate both the legs	Other	Group E Leg elevation
leg wrappingEsmarch bandage is used to wrap each lower limb	Other	Group W Leg wrapping
controlno intervention has been done	Other	Group C Control

Primary outcome

incidence of hypotension at baseline
Time frame: baseline
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 0 minutes after leg elevation or wrapping
Time frame: 0 minutes after leg elevation or wrapping
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 0 minutes after induction with propofol
Time frame: 0 minutes after induction with propofol
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 1 minute after induction
Time frame: 1 minute after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 2 minutes after induction
Time frame: 2 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 3 minutes after induction
Time frame: 3 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 4 minutes after induction
Time frame: 4 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 5 minutes after induction
Time frame: 5 minutes after induction
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 0 minutes after intubation
Time frame: 0 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 1 minute after intubation
Time frame: 1 minute after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 2 minutes after intubation
Time frame: 2 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 3 minutes after intubation
Time frame: 3 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 4 minutes after intubation
Time frame: 4 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 5 minutes after intubation
Time frame: 5 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 6 minutes after intubation
Time frame: 6 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 7 minutes after intubation
Time frame: 7 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 8 minutes after intubation
Time frame: 8 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 9 minutes after intubation
Time frame: 9 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.
incidence of hypotension at 10 minutes after intubation
Time frame: 10 minutes after intubation
Patient will be shifted to operation theatre. Non-invasive blood pressure (NIBP) monitor will be attached. Baseline blood pressure including systolic, diastolic and mean arterial blood pressures will be noted. Analgesia will be given by inj fentanyl. Lower limbs will be elevated, wrapped or none according to group allocation. Blood pressures will be recorded again. 3 minutes of pre-oxygenation will be done. Anaesthesia will be induced with inj. propofol 2mg/kg body weight injected over 30 seconds. Blood pressures will be noted at induction with propofol and for every minute till 5 minutes after induction. Muscle relaxation will be achieved by inj. vecuronium. Patient will be ventilated with oxygen for 5 minutes. Orotracheal intubation will be performed with appropriate sized endotracheal tube. Hypotension will be defined as a drop in systolic blood pressure to less than 30% of baseline values or to MAP <60mm Hg. Incidence of hypotension will be noted.

71 secondary outcomes

Magnitude of change in systolic blood pressure from baseline at 0 minutes after leg leg elevation or wrapping
Time frame: baseline, after leg elevation or wrapping
Magnitude of change in systolic blood pressure from baseline at 0 minutes after induction
Time frame: baseline, at 0 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 1 minute after induction
Time frame: baseline, at 1 minute after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 2 minutes after induction
Time frame: baseline, at 2 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 3 minutes after induction
Time frame: baseline, at 3 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 4 minutes after induction
Time frame: baseline, at 4 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 5 minutes after induction
Time frame: baseline, at 5 minutes after induction with propofol
Magnitude of change in systolic blood pressure from baseline at 0 minutes after intubation
Time frame: baseline, at 0 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 1 minute after intubation
Time frame: baseline, at 1 minute after intubation
Magnitude of change in systolic blood pressure from baseline at 2 minutes after intubation
Time frame: baseline, at 2 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 3 minutes after intubation
Time frame: baseline, at 3 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 4 minutes after intubation
Time frame: baseline, at 4 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 5 minutes after intubation
Time frame: baseline, at 5 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 6 minutes after intubation
Time frame: baseline, at 6 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 7 minutes after intubation
Time frame: baseline, at 7 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 8 minutes after intubation
Time frame: baseline, at 8 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 9 minutes after intubation
Time frame: baseline, at 9 minutes after intubation
Magnitude of change in systolic blood pressure from baseline at 10 minutes after intubation
Time frame: baseline, at 10 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 0 minutes after leg elevation or wrapping
Time frame: baseline, at 0 minutes after leg elevation or wrapping, at induction with propofol, every minute till 5 minutes after induction, at intubation and every minute thereafter upto 10 min post intubation
Magnitude of change in diastolic blood pressure from baseline at 0 minutes after induction with propofol
Time frame: baseline, at 0 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 1 minute after induction with propofol
Time frame: baseline, at 1 minute after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 2 minutes after induction with propofol
Time frame: baseline, at 2 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 3 minutes after induction with propofol
Time frame: baseline, at 3 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 4 minutes after induction with propofol
Time frame: baseline, at 4 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 5 minutes after induction with propofol
Time frame: baseline, at 5 minutes after induction with propofol
Magnitude of change in diastolic blood pressure from baseline at 0 minutes after intubation
Time frame: baseline, at 0 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 1 minute after intubation
Time frame: baseline, at 1 minute after intubation
Magnitude of change in diastolic blood pressure from baseline at 2 minutes after intubation
Time frame: baseline, at 2 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 3 minutes after intubation
Time frame: baseline, at 3 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 4 minutes after intubation
Time frame: baseline, at 4 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 5 minutes after intubation
Time frame: baseline, at 5 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 6 minutes after intubation
Time frame: baseline, at 6 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 7 minutes after intubation
Time frame: baseline, at 7 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 8 minutes after intubation
Time frame: baseline, at 8 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 9 minutes after intubation
Time frame: baseline, at 9 minutes after intubation
Magnitude of change in diastolic blood pressure from baseline at 10 minutes after intubation
Time frame: baseline, at 10 minutes after intubation
Magnitude of change in mean arterial blood pressure from baseline at 0 minutes after leg elevation or wrapping
Time frame: baseline, 0 minutes after leg elevation or wrapping
Magnitude of change in mean arterial blood pressure from baseline at 1 minute after induction with propofol
Time frame: baseline, 0 minute after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 2 minutes after induction with propofol
Time frame: baseline, 2 minutes after induction with propofol
Magnitude of change in mean arterial blood pressure from baseline at 3 minutes after induction with propofol
Time frame: baseline, 3 minutes after induction with propofol

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
Background: PubMed 3046442McNeir DA, Mainous EG, Trieger N. Propofol as an intravenous agent in general anesthesia and conscious sedation. Anesth Prog. 1988 Jul-Aug;35(4):147-51.
Background: PubMed 1595920Muzi M, Berens RA, Kampine JP, Ebert TJ. Venodilation contributes to propofol-mediated hypotension in humans. Anesth Analg. 1992 Jun;74(6):877-83. doi: 10.1213/00000539-199206000-00017.
Background: PubMed 8494130Rout CC, Rocke DA, Gouws E. Leg elevation and wrapping in the prevention of hypotension following spinal anaesthesia for elective caesarean section. Anaesthesia. 1993 Apr;48(4):304-8. doi: 10.1111/j.1365-2044.1993.tb06948.x.
Background: PubMed 24497858Masoudifar M, Beheshtian E. Comparison of cardiovascular response to laryngoscopy and tracheal intubation after induction of anesthesia by Propofol and Etomidate. J Res Med Sci. 2013 Oct;18(10):870-4.
Background: PubMed 23166149Moller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate: a double-blind, randomized, clinical trial. Br J Anaesth. 2013 Mar;110(3):388-96. doi: 10.1093/bja/aes416. Epub 2012 Nov 19.
Background: PubMed 16115962Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
BackgroundSingh K, Payal YS, Sharma JP, Nautiyal R. Evaluation of hemodynamic changes after leg wrapping in elective cesarean section under spinal anesthesia. J Obstet Anaesth Crit Care. 2014;4:23-8
Individual participant dataSharing planned: Yes. Age, sex, weight, diagnosis, surgery, asa physical status, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sara Jaison, MBBS contact

09846863119

sara_jaison@yahoo.co.in

Sripada G Mehandale, MBBS, MD contact

09448384310

dr_sgmehandale@rediffmail.com

Sripada G Mehandale, MBBS, MD study director

Associate Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing leg elevation and leg wrapping in people with Propofol Induced Hypotension, run by Nitte University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara Jaison, MBBS (09846863119, sara_jaison@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of hypotension at baseline (time frame: baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845921, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.