Effect of Dexmedetomidine on Hemodynamic Response to Endotracheal Intubation in Hypertensive Patients
NCT ID: NCT06712186
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2024-06-22
2024-12-01
Brief Summary
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1. \_Reduced anxiety and stress\_: Dexmedetomidine's anxiolytic and sedative effects help reduce anxiety and stress associated with endotracheal intubation.
2. \_Improved intubating conditions\_: Dexmedetomidine can improve intubating conditions by reducing the incidence of coughing, bucking, and laryngospasm.
3. \_Decreased hemodynamic responses\_: Dexmedetomidine can attenuate the hemodynamic responses to intubation, including tachycardia, hypertension, and increased cardiac output.
4. \_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:
1. \_Decreased heart rate\_: Dexmedetomidine can cause a decrease in heart rate due to its effects on the sympathetic nervous system.
2. \_Decreased blood pressure\_: Dexmedetomidine can also cause a decrease in blood pressure due to its vasodilatory effects.
3. \_Increased sedation\_: Dexmedetomidine's sedative effects can help reduce anxiety and stress during intubation.
4. \_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:
1. \_Improved patient comfort\_: Dexmedetomidine's sedative and anxiolytic effects can improve patient comfort during intubation.
2. \_Reduced need for additional anesthetics\_: Dexmedetomidine can reduce the need for additional anesthetics or muscle relaxants during intubation.
3. \_Decreased risk of complications\_: Dexmedetomidine's effects on hemodynamic responses and respiratory rate can decrease the risk of complications during intubation.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention group/Group D
Intervention group: Group D patients will be administer 0.5 mcg/kg dexmedetomidine intravenously over 10 min preoperatively.
Dexmedetomidine Group / Group D
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.
Control group/Group C
Control group: Group C patients will be administer the same volume of normal saline (also intravenously for 10 min)
Normal Saline (Placebo)
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.
Interventions
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Dexmedetomidine Group / Group D
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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Allergic to dexmedetomidine
* Non complaint hypertensive patients
* Patients with uncontrolled hypertension.
60 Years
ALL
No
Sponsors
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Liaquat National Hospital & Medical College
OTHER
Responsible Party
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Warisha Ismail
Warisha Ismail Dr, FCPS I
Principal Investigators
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Warisha ismail Dr Warisha ismail
Role: PRINCIPAL_INVESTIGATOR
Liaquat National Hospital and Medical College
Locations
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Liaquat National Hospital and Medical College
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Related Links
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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 anesthesia
Other Identifiers
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App #0877-2023-LNH-ERC
Identifier Type: -
Identifier Source: org_study_id