A Phase 1/2 interventional study of Dexmedetomidine Group / Group D and Normal Saline (Placebo) in Elective Surgical Patient, Hypertensive Patients and Blood Pressure, sponsored by Liaquat National Hospital & Medical College. Recruiting at 1 site in Pakistan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Liaquat National Hospital & Medical College · Phase 1/2, Interventional, and Prevention
Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to provide several benefits during endotracheal intubation:
The physiological responses to dexmedetomidine during intubation include:
The clinical benefits of dexmedetomidine during intubation include:
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Liaquat National Hospital & Medical College is the lead sponsor of 33 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Intervention group: Group D patients will be administer 0.5 mcg/kg dexmedetomidine intravenously over 10 min preoperatively.
Drug: Dexmedetomidine Group / Group D
Control group: Group C patients will be administer the same volume of normal saline (also intravenously for 10 min)
Other: Normal Saline (Placebo)
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.
Also known as: Dexemeditomidine
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.
Also known as: normal saline
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.
Time frame: At 5 minutes after laryngoscopy and endotracheal intubation.
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.
Time frame: 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.
Time frame: Baseline & 5 minutes
Plan to share: 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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Liaquat National Hospital & Medical College