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临床试验/CTRI/2025/11/097597
CTRI/2025/11/097597尚未招募2 期

A comparative study of effect of pre-treatment with oral Gabapentin versus Melatonin versus Clonidine on hemodynamic response to laryngoscopy and tracheal intubation in controlled hypertensive patients: A double-blinded, randomized controlled study.

All India Institute of Medical Sciences Raipur1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
108
试验地点
1
主要终点
To determine which of the following drugs, Gabapentin, Melatonin or Clonidine will blunt the hemodynamic changes caused during laryngoscopy and intubation better in treated hypertensive patients.

研究概览

简要总结

Title of the study: 

A comparative study of effect of pre-treatment with oral Gabapentin versus Melatonin versus Clonidine on hemodynamic response to laryngoscopy and tracheal intubation in controlled hypertensive patients: A double-blinded, randomized controlled study.

Background:

Direct laryngoscopy and endotracheal intubation cause a reflex sympathetic response that leads to increased heart rate, blood pressure, and risk of arrhythmias. This response usually peaks within one to two minutes and settles by five to six minutes, though tachycardia may last up to ten minutes. Hypertensive patients are more vulnerable due to their higher risk of heart and brain vessel diseases. Gabapentin, originally used for epilepsy and neuropathic pain, may reduce this response possibly through calcium channel modulation. Melatonin, a natural hormone with sedative and anxiolytic effects, has also been shown to reduce cardiovascular changes during intubation. Clonidine, a drug for high blood pressure with central sympatholytic effects, can similarly blunt the hemodynamic response when given as premedication.

Justification of the study:

Various drugs like calcium channel blockers, beta blockers, and opioids have been used to reduce the hemodynamic response to laryngoscopy and intubation to prevent complications such as myocardial ischemia and cerebral hemorrhage. Recently, clonidine, gabapentin, and melatonin have been studied for this purpose. This study aims to compare their effectiveness in attenuating the pressor response in treated hypertensive patients, a group for which limited data is available.

Objective:

This study aims to compare the effectiveness of Gabapentin, Melatonin, and Clonidine in blunting the hemodynamic response to laryngoscopy and intubation in treated hypertensive patients. In addition to evaluating the primary outcome, the study will also assess patients’ anxiety levels prior to induction and monitor for any side effects associated with the use of these study drugs.

Methodology:

In this study, eligible patients who provided consent were randomized and allocated into three groups. Each group received pretreatment one hour before induction: Group A was given oral Gabapentin 300 mg, Group B received oral Melatonin 3 mg, and Group C was administered oral Clonidine 100 mcg. Following pretreatment, all patients underwent laryngoscopy and endotracheal intubation. Patients who required multiple intubation attempts or had an intubation time exceeding 30 seconds were excluded from the study. Data from the remaining participants were collected and subjected to statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18 and 60 years
  • Patients giving written informed consent
  • Controlled hypertensive patients on treatment with BP less than 130/80mmHg
  • ASA grade II patients
  • Patients undergoing elective surgery under General anaesthesia.

排除标准

  • Patients taking Gabapentin, Melatonin or Clonidine
  • Patients having anticipated difficult airway
  • Patients with other coexisting diseases like Diabetes, Ischemic heart disease, Renal or Hepatic disorders, Arrhythmias.
  • Body Mass Index greater than 25 kg/m²
  • Patients on Beta blockers.

结局指标

主要结局

To determine which of the following drugs, Gabapentin, Melatonin or Clonidine will blunt the hemodynamic changes caused during laryngoscopy and intubation better in treated hypertensive patients.

时间窗: 1. Baseline vitals prior to induction of anesthesia | 2. Vitals during laryngoscopy and tracheal intubation | 3. Vitals 1,2,3,4,5,10,15 minutes after intubation

次要结局

  • To determine the Visual Analogue Scale for anxiety (VAS-A) of the patients(1. VAS-A prior to administration of premedication)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Prathibha R Mudgal

AIIMS Raipur

研究点 (1)

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