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临床试验/CTRI/2021/03/032319
CTRI/2021/03/032319尚未招募不适用

comparison of oral premedication with clonidine versus pregabalin for hemodunamic stability during laproscopic cholecystectomy under general anesthesia : a double blinded randomized control study

S Nijalingappa Medical College and HSK Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Both the drugs to be efficacious in maintaining hemodynamic stability and clonidine to be superior to pregabalin in maintaining hemodynamic stability during laparoscopic cholecystectomy

研究概览

简要总结

Comparison of oral premedication with clonidine versus pregabalin for hemodynamic stability during laparoscopic cholecystectomy under general anaesthesia : A double blinded randomized control study.

Laparoscopic surgeries are now a days being the standard approach for most common surgical procedures. It has gained popularity in clinical practice in view of shorter hospital stay, early ambulation, smaller incisional scar, and less compromised postoperative respiratory and gastrointestinal function. However it is associated with significant intraoperative haemodynamic changes largely due to creation of carbon-di-oxide pneumoperitoneum to facilitate the surgery. Mechanical effects of pneumoperitoneum, systemic absorption of carbon-di-oxide (CO2) causing release of catecholamines and patient positioning also contribute to various unfavourable haemodynamic responses. These surgeries are done under general  anaesthesia with direct laryngoscopy for tracheal intubation which is associated with autonomic changes like tachycardia, hypertension and dysrhythmias  which are usually well  tolerated in ASA grade I & II patients and maybe detrimental in patients with pre-existing diseases.

Clonidine is an α-2 adrenoreceptor agonist with central sympatholytic effect. Premedication with clonidine blunts the haemodynamic stress responses to direct laryngoscopy and tracheal intubation and it also stabilizes blood pressure by increasing cardiac baroreceptor reflex sensitivity. Pregabalin, a gabapentinoid compound appears to produce an inhibitory modulation of neuronal excitability particularly in neocortex, amygdala and hippocampus of CNS. It possess analgesic, anticonvulsant and anxiolytic activity by reduction of neurotransmitter glutamate, nor-adrenaline, serotonin, dopamine and substance P.

The aim of the study is to compare the efficacy of oral clonidine with oral Pregabalin in maintaining hemodynamic stability during laparoscopic cholecystectomy under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • ASA physical status I and II Body mass index less than or equals to 30 kg/m2 Patients undergoing Laparoscopic cholecystectomy.

排除标准

  • Patient refusal to give consent History of substance abuse Patients on antihypertensives Hepatic or renal dysfunction Pregnant or lactating females Anticipated difficult airway.

结局指标

主要结局

Both the drugs to be efficacious in maintaining hemodynamic stability and clonidine to be superior to pregabalin in maintaining hemodynamic stability during laparoscopic cholecystectomy

时间窗: 6 hours

次要结局

  • compared to clonidine pregabalin has better preoperative and post operative sedation.(6 hours)

研究者

发起方
S Nijalingappa Medical College and HSK Hospital
申办方类型
Private medical college

研究点 (1)

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