AnesthesiaPhase 4NCT02599168
Effect of Dexmedetomidine on Propofol Requirement During Anesthesia
A Phase 4 study testing Propofol and Dexmedetomidine in people with Anesthesia, run by Dr Nitin Sethi at 1 site in India.
Trial summary
Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in intensive care patients in receipt of mechanical ventilation, is being increasingly utilized in anaesthesia practice for facilitating anaesthesia depth as an adjunct to base anaesthetics (intravenous; propofol: inhalational… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 5 Dec 2015to 20 Mar 2017
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I/II
- Undergoing elective laparoscopic / robotic surgery of more than 60-minutes duration
Who cannot join
- Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)
- Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks)
- Any hepato-renal insufficiency
- Uncontrolled diabetes mellitus
- Known allergy/hypersensitivity to study drug
- Pulmonary dysfunction (restrictive /obstructive lung disease)
- Acute/chronic drug dependence/substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine on Propofol Requirements During Anesthesia Administered by Bispectral Index-Guided Closed-Loop Anesthesia Delivery System: A Randomized Controlled Study
Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in intensive care patients in receipt of mechanical ventilation, is being increasingly utilized in anaesthesia practice for facilitating anaesthesia depth as an adjunct to base anaesthetics (intravenous; propofol: inhalational; sevoflurane, desflurane). The investigators intend to assess the anaesthetic potential of dexmedetomidine in controlled anaesthesia settings empowered by the use of an objective, patient response based, safe, efficient, and patented closed loop anaesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anaesthetized patients with the help of a BIS- monitor, which is continuously fed into a automated drug infusion pump. The infusion pump then accordingly delivers the anaesthetic drug to the patients based on pharmacodynamic requirements. If dexmedetomidine has anaesthesia potential then it is likely that propofol use delivered by CLADS can be reduced further. In addition the effect of two drugs (viz, base agent-propofol plus adjunct agent-dexmedetomidine) on different receptor site within the brain would help gain greater anaesthetic depth consistency as well as a lower incidence of intraoperative patient awareness. This prospective randomized two-arm study aims to assess effect of the use of dexmedetomidine on propofol requirements (primary objective), anaesthesia depth consistency, and intraoperative patient awareness (secondary objectives).
Read the detailed description
After Institutional Ethics Committee approval and written informed consent, eighty patient-participants (40 per group) aged 20-65 years, ASA physical status I/II, of either sex, and undergoing major laparoscopic / robotic surgery of more than 60-minutes duration will be included in this single-center (Sir Ganga Ram Hospital, New Delhi-110060, India ) prospective, double-blinded, two-arm, randomized controlled study.
The patients will be randomly divided into two groups:
Group-I: Pre-induction dexmedetomidine + intraoperative dexmedetomidine plus anesthesia with propofol delivered by CLADS (induction + maintenance) [Dexmedetomidine group] Group-II: Pre-induction 0.9% saline solution + intraoperative 0.9% saline solution infusion + anesthesia with propofol delivered by CLADS (induction + maintenance) [Non Dexmedetomidine group]
Sample-size Estimation:
The sample size estimation was estimated from the cue that the average propofol doses required for maintenance of anaesthesia (4.7+ 1.6 mg/kg/hr) when using manual propofol and remifentanil target controlled infusion18 with a 90% power employed to detect a 30% decrease of propofol dosage among the patients who will receive dexmedetomidine in addition to base anesthetic propofol; with a bilateral α risk value of 0.05, the investigators would require 66 patients for the study. To cover up for unanticipated losses the investigators would need additional 20% patients. Thus the investigators would require 80-patients for the study
Randomization, Allocation Concealment:
The patients will be randomly allocated to one of the two groups based on a computer-generated random number table (url:stattrek.com/statistics/random-number-generator.aspx). Randomization sequence concealment will include opaque-sealed envelopes with alphabetic codes whose distribution will be in control of an independent analyst. The envelopes will be opened; patient's data-slip will be pasted on them, and will be sent back to the control analyst.
Management of Anaesthesia:
Two peripheral venous lines (18G/20G catheter) will be secured. Invasive vascular access (arterial line for direct continuous blood pressure assessment, central venous catheter) will be secured as per the requirement of surgery and/or patients morbid status. A BIS sensor (Covidien IIc, Mansfield, USA) for monitoring depth of anaesthesia, using the BIS monitoring module (Model DSC-XP, Aspect medical system, USA), will be applied over the patient's forehead according to manufacturer's instruction prior to induction of anaesthesia.
The patients will be randomly allocated to one of the two groups separated by method of dexmedetomidine administration. The pre-induction and the infusion dose of dexmedetomidine will be 1-µ/kg over 10 minutes and 0.5-µ/kg/hour, respectively. Dexmedetomidine infusion will be stopped in case of acute haemodynamic suppression (>20% pre-induction baseline) or acute blood loss (>200-ml) at any point of time and it will be recorded as an event. It will be restarted upon normalcy of haemodynamics is achieved and also full surgical hemostasis is ensured.
Anesthesia Technique:
All the patients will be administered pre-induction fentanyl-citrate analgesia as per a predefined strategy (total 2-µg/kg IV: 1-µg/kg at 0 minute, 3-minutes time points]. Pre-oxygenation will be initiated at 6-minute time point or prior to that if there is a fall in oxygen saturation < 94 percent. At 9-minute time point anaesthesia will be induced with propofol 2-mg/kg and vecuronium bromide 0.08-mg/kg for skeletal muscle relaxation to facilitate tracheal intubation. Ventilator settings of CMV, tracheal tube size [7.5-mm I.D (male), 6.5-mm I.D (female)] and breathing circuit (circle-CO2 absorber system) will be the standardized in all the patients. Routine monitoring (EKG, NIBP, pulse oximetery, EtCO2) will be applied during the procedure as per the established practice. Over and above the use of study drug dexmedetomidine as per group allocation, propofol administration will be controlled with CLADS system tuned to consistent anaesthetic depth (BIS 40-60) in all the patients. In addition, all the patients will receive 0.5-µg/kg/hr fentanyl infusion during surgery. Oxygen.-air mixture (FiO2 0.50) will be utilized for intraoperative ventilation. Neostigmine (50-µg/kg) and glycopyrrolate (20-µg/kg) will be administered to reverse the residual neuromuscular blockade (non-depolariser).
- Conditions
- Anesthesia
- Being tested
- Propofol, Dexmedetomidine, Placebo (normal saline)
- Keywords
- dexmedetomidine, propofol, BIS, CLADS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
DexmedetomidineDrug
Placebo (normal saline)Drug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Active comparator | Patients will receive a pre-induction loading dose of dexmedetomidine 1-µ/kg over 10 minutes followed by an intraoperative infusion of 0.5-µ/kg/hour . Over and above the use of study drug dexmedetomidine propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients Receives: Drug: Propofol; Drug: Dexmedetomidine |
| Non-Dexmedetomidine group | Placebo comparator | Patients will receive a pre-induction loading dose of 0.9% saline solution over 10 minutes followed by an intraoperative infusion.Over and above the use of 0.9% saline solution propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients Receives: Drug: Propofol; Drug: Placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Propofol usage in milligrams
Comparison of 'dexmedetomidine' versus 'no dexmedetomidine' administration in decreasing quantitative propofol requirements (measured in milligrams) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based general anaesthesia.
Measured: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Assessment of change in anaesthesia depth using Bi-spectral index score
Comparison of anaesthesia depth adequacy in intervention (with dexmedetomidine) versus control (without dexmedetomidine) using Varvel criteria to assess Bi-spectral index (BIS) score consistency during closed loop anaesthesia delivery system empowered and BIS-controlled propofol-based general anaesthesia
Measured: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Secondary outcomes (6)
Change in Intraoperative heart Rate (beats per minute)
Comparison of intraoperative heart rate in the 'intervention' (with dexmedetomidine) versus 'control' (without dexmedetomidine) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based GA
Measured: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Change in Intraoperative blood pressure - systolic , diastolic, and mean (mmHg)
Comparison of intraoperative blood pressure (systolic , diastolic, and mean) in the 'intervention' (with dexmedetomidine) versus 'control' (without dexmedetomidine) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based GA
Measured: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Postoperative sedation
Will be assessed using Observer asssesment of Alertness/Sedation Scale (OAAS)
Measured: From the end of anaesthesia till 24-hours, postoperatively
Intraoperative awareness
Will be assessed using modified brice questionnaire
Measured: From the end of anaesthesia till 48-hours, postoperatively
Postoperative nausea and vomiting
Will be assessed using PONV scale
Measured: From the end of anaesthesia till 24-hours, postoperatively
Postoperative Analgeisa
Will be assessed using Visual Analogue Scale (VAS) Score
Measured: From the end of anaesthesia till 24-hours, postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start5 Dec 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Nitin Sethi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Nitin Sethi, Sir Ganga Ram Hospital
- Investigators
- Goverdhan D Puri, MD, PhD, Study director, Post Graduate Institute of Medical Education & Research, Chandigarh, IndiaJayashree Sood, MD, FFRCA, Study chair, Sir Ganga Ram Hospital, New Delhi, INDIAAmitabh Dutta, MD, Principal investigator, Sir Ganga Ram Hospital, New Delhi, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599168
- Sponsor's protocol ID
- EC/04/15/807
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2015
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dutta A, Sethi N, Sood J, Panday BC, Gupta M, Choudhary P, Puri GD. The Effect of Dexmedetomidine on Propofol Requirements During Anesthesia Administered by Bispectral Index-Guided Closed-Loop Anesthesia Delivery System: A Randomized Controlled Study. Anesth Analg. 2019 Jul;129(1):84-91. doi: 10.1213/ANE.0000000000003470.
PubMed 29787410
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Propofol Requirements During Anesthesia Administered by Bispectral Index-Guided Closed-Loop Anesthesia Delivery System: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02599168
- Acronym / sponsor ID
- EC/04/15/807
- Conditions
- Anesthesia
- Keywords
- dexmedetomidine, propofol, BIS, CLADS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr Nitin SethiUniversity, hospital or other
- Study start
- 5 Dec 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 6 Nov 2015 (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.
Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in intensive care patients in receipt of mechanical ventilation, is being increasingly utilized in anaesthesia practice for facilitating anaesthesia depth as an adjunct to base anaesthetics (intravenous; propofol: inhalational; sevoflurane, desflurane). The investigators intend to assess the anaesthetic potential of dexmedetomidine in controlled anaesthesia settings empowered by the use of an objective, patient response based, safe, efficient, and patented closed loop anaesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anaesthetized patients with the help of a BIS- monitor, which is continuously fed into a automated drug infusion pump. The infusion pump then accordingly delivers the anaesthetic drug to the patients based on pharmacodynamic requirements. If dexmedetomidine has anaesthesia potential then it is likely that propofol use delivered by CLADS can be reduced further. In addition the effect of two drugs (viz, base agent-propofol plus adjunct agent-dexmedetomidine) on different receptor site within the brain would help gain greater anaesthetic depth consistency as well as a lower incidence of intraoperative patient awareness. This prospective randomized two-arm study aims to assess effect of the use of dexmedetomidine on propofol requirements (primary objective), anaesthesia depth consistency, and intraoperative patient awareness (secondary objectives).
Detailed description
After Institutional Ethics Committee approval and written informed consent, eighty patient-participants (40 per group) aged 20-65 years, ASA physical status I/II, of either sex, and undergoing major laparoscopic / robotic surgery of more than 60-minutes duration will be included in this single-center (Sir Ganga Ram Hospital, New Delhi-110060, India ) prospective, double-blinded, two-arm, randomized controlled study.
The patients will be randomly divided into two groups:
Group-I: Pre-induction dexmedetomidine + intraoperative dexmedetomidine plus anesthesia with propofol delivered by CLADS (induction + maintenance) [Dexmedetomidine group] Group-II: Pre-induction 0.9% saline solution + intraoperative 0.9% saline solution infusion + anesthesia with propofol delivered by CLADS (induction + maintenance) [Non Dexmedetomidine group]
Sample-size Estimation:
The sample size estimation was estimated from the cue that the average propofol doses required for maintenance of anaesthesia (4.7+ 1.6 mg/kg/hr) when using manual propofol and remifentanil target controlled infusion18 with a 90% power employed to detect a 30% decrease of propofol dosage among the patients who will receive dexmedetomidine in addition to base anesthetic propofol; with a bilateral α risk value of 0.05, the investigators would require 66 patients for the study. To cover up for unanticipated losses the investigators would need additional 20% patients. Thus the investigators would require 80-patients for the study
Randomization, Allocation Concealment:
The patients will be randomly allocated to one of the two groups based on a computer-generated random number table (url:stattrek.com/statistics/random-number-generator.aspx). Randomization sequence concealment will include opaque-sealed envelopes with alphabetic codes whose distribution will be in control of an independent analyst. The envelopes will be opened; patient's data-slip will be pasted on them, and will be sent back to the control analyst.
Management of Anaesthesia:
Two peripheral venous lines (18G/20G catheter) will be secured. Invasive vascular access (arterial line for direct continuous blood pressure assessment, central venous catheter) will be secured as per the requirement of surgery and/or patients morbid status. A BIS sensor (Covidien IIc, Mansfield, USA) for monitoring depth of anaesthesia, using the BIS monitoring module (Model DSC-XP, Aspect medical system, USA), will be applied over the patient's forehead according to manufacturer's instruction prior to induction of anaesthesia.
The patients will be randomly allocated to one of the two groups separated by method of dexmedetomidine administration. The pre-induction and the infusion dose of dexmedetomidine will be 1-µ/kg over 10 minutes and 0.5-µ/kg/hour, respectively. Dexmedetomidine infusion will be stopped in case of acute haemodynamic suppression (>20% pre-induction baseline) or acute blood loss (>200-ml) at any point of time and it will be recorded as an event. It will be restarted upon normalcy of haemodynamics is achieved and also full surgical hemostasis is ensured.
Anesthesia Technique:
All the patients will be administered pre-induction fentanyl-citrate analgesia as per a predefined strategy (total 2-µg/kg IV: 1-µg/kg at 0 minute, 3-minutes time points]. Pre-oxygenation will be initiated at 6-minute time point or prior to that if there is a fall in oxygen saturation < 94 percent. At 9-minute time point anaesthesia will be induced with propofol 2-mg/kg and vecuronium bromide 0.08-mg/kg for skeletal muscle relaxation to facilitate tracheal intubation. Ventilator settings of CMV, tracheal tube size [7.5-mm I.D (male), 6.5-mm I.D (female)] and breathing circuit (circle-CO2 absorber system) will be the standardized in all the patients. Routine monitoring (EKG, NIBP, pulse oximetery, EtCO2) will be applied during the procedure as per the established practice. Over and above the use of study drug dexmedetomidine as per group allocation, propofol administration will be controlled with CLADS system tuned to consistent anaesthetic depth (BIS 40-60) in all the patients. In addition, all the patients will receive 0.5-µg/kg/hr fentanyl infusion during surgery. Oxygen.-air mixture (FiO2 0.50) will be utilized for intraoperative ventilation. Neostigmine (50-µg/kg) and glycopyrrolate (20-µg/kg) will be administered to reverse the residual neuromuscular blockade (non-depolariser).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: Propofol, Drug: DexmedetomidinePatients will receive a pre-induction loading dose of dexmedetomidine 1-µ/kg over 10 minutes followed by an intraoperative infusion of 0.5-µ/kg/hour . Over and above the use of study drug dexmedetomidine propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients |
| Non-Dexmedetomidine group | Placebo comparator | Drug: Propofol, Drug: Placebo (normal saline)Patients will receive a pre-induction loading dose of 0.9% saline solution over 10 minutes followed by an intraoperative infusion.Over and above the use of 0.9% saline solution propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I/II
- Undergoing elective laparoscopic / robotic surgery of more than 60-minutes duration
Key exclusion criteria (7 listed)
- Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)
- Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks)
- Any hepato-renal insufficiency
- Uncontrolled diabetes mellitus
- Known allergy/hypersensitivity to study drug
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 |
|---|---|---|
| Propofol | Drug | Dexmedetomidine group, Non-Dexmedetomidine group |
| Dexmedetomidine | Drug | Dexmedetomidine group |
| Placebo (normal saline) | Drug | Non-Dexmedetomidine group |
Primary outcome
Change in Propofol usage in milligrams
Time frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Comparison of 'dexmedetomidine' versus 'no dexmedetomidine' administration in decreasing quantitative propofol requirements (measured in milligrams) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based general anaesthesia.
Assessment of change in anaesthesia depth using Bi-spectral index score
Time frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Comparison of anaesthesia depth adequacy in intervention (with dexmedetomidine) versus control (without dexmedetomidine) using Varvel criteria to assess Bi-spectral index (BIS) score consistency during closed loop anaesthesia delivery system empowered and BIS-controlled propofol-based general anaesthesia
6 secondary outcomes
Change in Intraoperative heart Rate (beats per minute)
Time frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Change in Intraoperative blood pressure - systolic , diastolic, and mean (mmHg)
Time frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively
Postoperative sedation
Time frame: From the end of anaesthesia till 24-hours, postoperatively
Intraoperative awareness
Time frame: From the end of anaesthesia till 48-hours, postoperatively
Postoperative nausea and vomiting
Time frame: From the end of anaesthesia till 24-hours, postoperatively
Postoperative Analgeisa
Time frame: From the end of anaesthesia till 24-hours, postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Derived from this study: PubMed 29787410Dutta A, Sethi N, Sood J, Panday BC, Gupta M, Choudhary P, Puri GD. The Effect of Dexmedetomidine on Propofol Requirements During Anesthesia Administered by Bispectral Index-Guided Closed-Loop Anesthesia Delivery System: A Randomized Controlled Study. Anesth Analg. 2019 Jul;129(1):84-91. doi: 10.1213/ANE.0000000000003470.
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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.
Goverdhan D Puri, MD, PhD study director
Post Graduate Institute of Medical Education & Research, Chandigarh, India
Jayashree Sood, MD, FFRCA study chair
Sir Ganga Ram Hospital, New Delhi, INDIA
Amitabh Dutta, MD principal investigator
Sir Ganga Ram Hospital, New Delhi, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Dexmedetomidine in people with Anesthesia, run by Dr Nitin Sethi 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 Oct 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Propofol usage in milligrams (time frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively). The study lists 2 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 NCT02599168, which also lists 1 linked publication.
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 4 Oct 2017.