Elective Surgical PatientPhase 1/2NCT06712186
Effect of Dexmedetomidine on Hemodynamic Response to Endotracheal Intubation in Hypertensive Patients
A Phase 1/2 study testing Dexmedetomidine Group / Group D in people with Elective Surgical Patient and Hypertensive Patients, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to provide several benefits during endotracheal intubation: 1. _Reduced anxiety and stress_: Dexmedetomidine's anxiolytic and sedative effects help reduce anxiety and stress associated with endotracheal intubation. 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elective Surgical Patient, Hypertensive Patients, Blood Pressure
- What is being tested?
- Dexmedetomidine Group / Group D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jun 2024to 1 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Grade II
- Age > 60 years
- Elective surgical procedures under GA.
- All patients with a diagnosis of hypertension for 6 months or more and undergoing treatment with antihypertensive medications.
Who cannot join
- Patient refusal
- ASA Grade III and IV
- Severely Hypovolemic state
- Emergency surgeries
- Body weight more than 20% of ideal body weight.
- Patients with known or unanticipated difficult intubation and those requiring more than 15 sec or two attempts at laryngoscopy
Show all 9Show fewer
- Allergic to dexmedetomidine
- Non complaint hypertensive patients
- Patients with uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Liaquat National Hospital and Medical College
Karachi, Sindh
About this study
Official title: Title: the Effects of Dexmedetomidine on Hemodynamic Responses to Endotracheal Intubation in Hypertensive Patients Undergoing Surgery
Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to provide several benefits during endotracheal intubation:
- _Reduced anxiety and stress_: Dexmedetomidine's anxiolytic and sedative effects help reduce anxiety and stress associated with endotracheal intubation.
- _Improved intubating conditions_: Dexmedetomidine can improve intubating conditions by reducing the incidence of coughing, bucking, and laryngospasm.
- _Decreased hemodynamic responses_: Dexmedetomidine can attenuate the hemodynamic responses to intubation, including tachycardia, hypertension, and increased cardiac output.
- _Increased ease of intubation_: Dexmedetomidine can facilitate smoother and easier intubation by reducing the need for additional anesthetics or muscle relaxants.
Read more
The physiological responses to dexmedetomidine during intubation include:
- _Decreased heart rate_: Dexmedetomidine can cause a decrease in heart rate due to its effects on the sympathetic nervous system.
- _Decreased blood pressure_: Dexmedetomidine can also cause a decrease in blood pressure due to its vasodilatory effects.
- _Increased sedation_: Dexmedetomidine's sedative effects can help reduce anxiety and stress during intubation.
- _Reduced respiratory rate_: Dexmedetomidine can cause a decrease in respiratory rate due to its effects on the respiratory centers in the brain.
The clinical benefits of dexmedetomidine during intubation include:
- _Improved patient comfort_: Dexmedetomidine's sedative and anxiolytic effects can improve patient comfort during intubation.
- _Reduced need for additional anesthetics_: Dexmedetomidine can reduce the need for additional anesthetics or muscle relaxants during intubation.
- _Decreased risk of complications_: Dexmedetomidine's effects on hemodynamic responses and respiratory rate can decrease the risk of complications during intubation.
Read the detailed description
General anesthesia during surgery produces a state of controlled unconsciousness during which the patient is unaware and insensitive to pain. Laryngoscopy and endotracheal intubation are mostly used to maintain airway while the patient is unconscious. Following the induction of anaesthesia, direct laryngoscopy and tracheal intubation are attributed to hemodynamic alterations brought on by sympathetic adrenergic outflow caused by laryngeal tissue stimulation, which may cause hypertension, tachycardia, arrhythmia, raised intracranial pressure, and intraocular pressure. The hemodynamic changes brought about by laryngoscopy and intubation were first described by Reid and Brace.This may be inconsequential in normal people but may lead to serious morbidity in patients with coexisting cerebrovascular or cardiovascular conditions.Patients undergoing treatment for hypertension have more pronounced hemodynamic responses to sympathetic stimulation.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with a distribution half-life of approximately 6 minutes frequently used in anesthesia practice. With only minimal respiratory depression and cardiovascular stability, dexmedetomidine produces sedation, hypnosis, analgesia, anxiolysis, and sympatholysis. The central effects are due to the activation of α-2A receptors in locus coeruleus, and cardiovascular effects are due to a dose-dependent decrease in the central sympathetic outflow. The transient hypertensive response is seen initially due to its effects on α-2B receptors present in the vascular smooth muscle until there is a decrease in the central sympathetic outflow.
The study's main aim is to assess the effectiveness of using dexmedetomidine as a preventative measure to lessen the sympathetic response caused by tracheal intubation in hypertensive individuals.
The objective of the study is to compare mean attenuation of stress response between groups given dexmedetomidine versus Normal Saline among hypertensive patients undergoing general anaesthesia with endotracheal intubation. We want to compare the effect of Dexmedetomidine on MAP at 5 minutes after laryngoscopy.
The study design is Prospective double blind Randomized Controlled Trial and will be conducted in Department of Anesthesia, Liaquat National hospital.
The 60 patients from Anesthesia Preoperative Clinic will be randomly allocated to 2 groups by using a closed-envelope method-a control group (group C) that will receive normal saline and a comparative group (group D) that will receive dexmedetomidine. Group D patients (n = 30) will be administer 0.5 mcg/kg dexmedetomidine (PrecedexTM; Hospira Inc., Lake Forest, IL, USA) intravenously over 10 min. Group C patients will be administer the same volume of normal saline (also intravenously for 10 min). Saline and dexmedetomidine will be administer using a syringe pump by an anesthesiologist unaware of the study protocol. After completing the saline or dexmedetomidine administration, Propofol (1.5-2.5mg/kg) titrated to effect and Atracurium (0.5 mg/kg) will be administer. Two minutes after these administrations, endotracheal intubation will be perform using a laryngoscope. All intubations will be performed within <30 sec by one anesthesiologist. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) will be recorded in the ward just before departure to the operating room (baseline value), immediately after study drug administration, and at 1, 3, and 5 min after endotracheal intubation.The primary outcome is MAP at 5 min while HR, Systolic blood pressure and diastolic blood pressure are secondary outcome.
Data will be analyzed by using IBM SPSS Statistics version 26. Normality will be checked by Shapiro w\Wilk test.Stratification will be done with regards to age, weight and duration of hypertension, gender, comorbid other than hypertension and drug used as per need and post stratification independent t test/ Mann-Whitney U-test will be applied. P<0.05 will be considered as significant.
- Conditions
- Elective Surgical Patient, Hypertensive Patients, Blood Pressure, Hypertensive Elderly Patients, Anxiolytic
- Being tested
- Dexmedetomidine Group / Group D, Normal Saline (Placebo)
- Keywords
- Laryngoscopy, Dexmedetomidine, Hemodynamic Response, Endotracheal intubation, Pressor response, Hypertension, Intubation, General anesthesia, a 2 agonist, Sedative, Anxiolytic
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Group / Group DDrug
Also called Dexemeditomidine
In this study, the intervention involve administrating 0.5 mcg/kg of Inj dexmedetomidine intravenously over 10 min to patients in intervention group/group D 2 minutes prior to Endotracheal intubation using laryngoscopy aiming to asses its efficacy in attenuating the pressor response to laryngoscopy.
Normal Saline (Placebo)Other
Also called normal saline
The Placebo group / group C will be administer Normal Saline without any active medication over 10 min to patients, 2 minutes prior to Endotracheal intubation using laryngoscopy to compare its effect to those of Dexmedetomidine in attenuating the pressor response to laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group/Group D | Experimental | Intervention group: Group D patients will be administer 0.5 mcg/kg dexmedetomidine intravenously over 10 min preoperatively. Receives: Drug: Dexmedetomidine Group / Group D |
| Control group/Group C | Placebo comparator | Control group: Group C patients will be administer the same volume of normal saline (also intravenously for 10 min) Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP)
The primary outcome is to measure the change in Mean Arterial Pressure before endotracheal intubation and 5 minutes after intubation.
An increase or decrease in MAP of 20 mmHg of patient's baseline MAP within 5 minutes of endotracheal intubation will be considered significant in our study.
The focus is on whether Dexmedetomidine maintain MAP with 20mmhg of patient's baseline reading.
Measured: At 5 minutes after laryngoscopy and endotracheal intubation.
Secondary outcomes (2)
Heart Rate (HR)
A increase or decrease in HR of 20 bpm of patient's baseline HR within 5 minutes of endotracheal intubation will be considered significant in our study.
Measured: Baseline & 5 minutes
Blood pressure (BP)
An increase or decrease in BP of 20 mmHg of patient's baseline BP within 5 minutes of endotracheal intubation will be considered significant in our study.
Measured: Baseline & 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start22 Jun 2024
- Primary completion22 Nov 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical PatientStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warisha Ismail, Liaquat National Hospital & Medical College
- Investigators
- Warisha ismail Dr Warisha ismail, Principal investigator, Liaquat National Hospital and Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712186
- Sponsor's protocol ID
- App #0877-2023-LNH-ERC
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: \*Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. IPD may require additional validation and quality control checks before sharing, which can be time-consuming and resource-intensive.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: the Effects of Dexmedetomidine on Hemodynamic Responses to Endotracheal Intubation in Hypertensive Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06712186
- Acronym / sponsor ID
- App #0877-2023-LNH-ERC
- Conditions
- Elective Surgical Patient, Hypertensive Patients, Blood Pressure, Hypertensive Elderly Patients, Anxiolytic
- Keywords
- Laryngoscopy, Dexmedetomidine, Hemodynamic Response, Endotracheal intubation, Pressor response, Hypertension, Intubation, General anesthesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Dec 2024 (actual)
- 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, an alpha-2 adrenergic agonist, has been shown to provide several benefits during endotracheal intubation:
- _Reduced anxiety and stress_: Dexmedetomidine's anxiolytic and sedative effects help reduce anxiety and stress associated with endotracheal intubation.
- _Improved intubating conditions_: Dexmedetomidine can improve intubating conditions by reducing the incidence of coughing, bucking, and laryngospasm.
- _Decreased hemodynamic responses_: Dexmedetomidine can attenuate the hemodynamic responses to intubation, including tachycardia, hypertension, and increased cardiac output.
- _Increased ease of intubation_: Dexmedetomidine can facilitate smoother and easier intubation by reducing the need for additional anesthetics or muscle relaxants.
The physiological responses to dexmedetomidine during intubation include:
- _Decreased heart rate_: Dexmedetomidine can cause a decrease in heart rate due to its effects on the sympathetic nervous system.
- _Decreased blood pressure_: Dexmedetomidine can also cause a decrease in blood pressure due to its vasodilatory effects.
- _Increased sedation_: Dexmedetomidine's sedative effects can help reduce anxiety and stress during intubation.
- _Reduced respiratory rate_: Dexmedetomidine can cause a decrease in respiratory rate due to its effects on the respiratory centers in the brain.
The clinical benefits of dexmedetomidine during intubation include:
- _Improved patient comfort_: Dexmedetomidine's sedative and anxiolytic effects can improve patient comfort during intubation.
- _Reduced need for additional anesthetics_: Dexmedetomidine can reduce the need for additional anesthetics or muscle relaxants during intubation.
- _Decreased risk of complications_: Dexmedetomidine's effects on hemodynamic responses and respiratory rate can decrease the risk of complications during intubation.
Detailed description
General anesthesia during surgery produces a state of controlled unconsciousness during which the patient is unaware and insensitive to pain. Laryngoscopy and endotracheal intubation are mostly used to maintain airway while the patient is unconscious. Following the induction of anaesthesia, direct laryngoscopy and tracheal intubation are attributed to hemodynamic alterations brought on by sympathetic adrenergic outflow caused by laryngeal tissue stimulation, which may cause hypertension, tachycardia, arrhythmia, raised intracranial pressure, and intraocular pressure. The hemodynamic changes brought about by laryngoscopy and intubation were first described by Reid and Brace.This may be inconsequential in normal people but may lead to serious morbidity in patients with coexisting cerebrovascular or cardiovascular conditions.Patients undergoing treatment for hypertension have more pronounced hemodynamic responses to sympathetic stimulation.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with a distribution half-life of approximately 6 minutes frequently used in anesthesia practice. With only minimal respiratory depression and cardiovascular stability, dexmedetomidine produces sedation, hypnosis, analgesia, anxiolysis, and sympatholysis. The central effects are due to the activation of α-2A receptors in locus coeruleus, and cardiovascular effects are due to a dose-dependent decrease in the central sympathetic outflow. The transient hypertensive response is seen initially due to its effects on α-2B receptors present in the vascular smooth muscle until there is a decrease in the central sympathetic outflow.
The study's main aim is to assess the effectiveness of using dexmedetomidine as a preventative measure to lessen the sympathetic response caused by tracheal intubation in hypertensive individuals.
The objective of the study is to compare mean attenuation of stress response between groups given dexmedetomidine versus Normal Saline among hypertensive patients undergoing general anaesthesia with endotracheal intubation. We want to compare the effect of Dexmedetomidine on MAP at 5 minutes after laryngoscopy.
The study design is Prospective double blind Randomized Controlled Trial and will be conducted in Department of Anesthesia, Liaquat National hospital.
The 60 patients from Anesthesia Preoperative Clinic will be randomly allocated to 2 groups by using a closed-envelope method-a control group (group C) that will receive normal saline and a comparative group (group D) that will receive dexmedetomidine. Group D patients (n = 30) will be administer 0.5 mcg/kg dexmedetomidine (PrecedexTM; Hospira Inc., Lake Forest, IL, USA) intravenously over 10 min. Group C patients will be administer the same volume of normal saline (also intravenously for 10 min). Saline and dexmedetomidine will be administer using a syringe pump by an anesthesiologist unaware of the study protocol. After completing the saline or dexmedetomidine administration, Propofol (1.5-2.5mg/kg) titrated to effect and Atracurium (0.5 mg/kg) will be administer. Two minutes after these administrations, endotracheal intubation will be perform using a laryngoscope. All intubations will be performed within <30 sec by one anesthesiologist. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) will be recorded in the ward just before departure to the operating room (baseline value), immediately after study drug administration, and at 1, 3, and 5 min after endotracheal intubation.The primary outcome is MAP at 5 min while HR, Systolic blood pressure and diastolic blood pressure are secondary outcome.
Data will be analyzed by using IBM SPSS Statistics version 26. Normality will be checked by Shapiro w\Wilk test.Stratification will be done with regards to age, weight and duration of hypertension, gender, comorbid other than hypertension and drug used as per need and post stratification independent t test/ Mann-Whitney U-test will be applied. P<0.05 will be considered as significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group/Group D | Experimental | Drug: Dexmedetomidine Group / Group DIntervention group: Group D patients will be administer 0.5 mcg/kg dexmedetomidine intravenously over 10 min preoperatively. |
| Control group/Group C | Placebo comparator | Other: Normal Saline (Placebo)Control group: Group C patients will be administer the same volume of normal saline (also intravenously for 10 min) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA Grade II
- Age > 60 years
- Elective surgical procedures under GA.
- All patients with a diagnosis of hypertension for 6 months or more and undergoing treatment with antihypertensive medications.
Key exclusion criteria (9 listed)
- Patient refusal
- ASA Grade III and IV
- Severely Hypovolemic state
- Emergency surgeries
- Body weight more than 20% of ideal body weight.
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 |
|---|---|---|
| Dexmedetomidine Group / Group DAlso: DexemeditomidineIn this study, the intervention involve administrating 0.5 mcg/kg of Inj dexmedetomidine intravenously over 10 min to patients in intervention group/group D 2 minutes prior to Endotracheal intubation using laryngoscopy aiming to asses its efficacy in attenuating the pressor response to laryngoscopy. | Drug | Intervention group/Group D |
| Normal Saline (Placebo)Also: normal salineThe Placebo group / group C will be administer Normal Saline without any active medication over 10 min to patients, 2 minutes prior to Endotracheal intubation using laryngoscopy to compare its effect to those of Dexmedetomidine in attenuating the pressor response to laryngoscopy. | Other | Control group/Group C |
Primary outcome
Mean Arterial Pressure (MAP)
Time frame: At 5 minutes after laryngoscopy and endotracheal intubation.
The primary outcome is to measure the change in Mean Arterial Pressure before endotracheal intubation and 5 minutes after intubation. An increase or decrease in MAP of 20 mmHg of patient's baseline MAP within 5 minutes of endotracheal intubation will be considered significant in our study. The focus is on whether Dexmedetomidine maintain MAP with 20mmhg of patient's baseline reading.
2 secondary outcomes
Heart Rate (HR)
Time frame: Baseline & 5 minutes
Blood pressure (BP)
Time frame: Baseline & 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Kore SS, Teresa Jose VS, Shah KS. Therapeutic Efficacy of dexmedetomidine on the pressor response due to endotracheal intubation and on the induction dose of propofol for surgeries under general anesthesiaLink provided by the sponsor.
- Individual participant dataSharing planned: No. *Informed consent*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. Patient confidentiality*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. IPD may require additional validation and quality control checks before sharing, which can be time-consuming and resource-intensive.
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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.
Warisha ismail Dr Warisha ismail principal investigator
Liaquat National Hospital and Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexmedetomidine Group / Group D in people with Elective Surgical Patient and Hypertensive Patients, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. 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 Pakistan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warisha Ismail Dr Warisha Ismail (+92 3046878028, khanveera97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (MAP) (time frame: At 5 minutes after laryngoscopy and endotracheal intubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024.