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临床试验/CTRI/2023/03/050162
CTRI/2023/03/050162尚未招募不适用

Comparison of two doses of Pregabalin for preventing Succinylcholine-induced fasciculations and myalgia in patients undergoing surgery under General Anaesthesia: A Randomized controlled study

Shri B M Patil Medical College1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2023年5月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
201
试验地点
1
主要终点
To compare the efficacy of two doses of Pregabalin in preventing Succinylcholine-Induced fasciculations and myalgia

研究概览

简要总结

This study is a Prospective Randomized,Parallel group,double blinded study.This study consists of 3 groups where Group A who will receive Capsule Pregabalin 75mg,Group B will receive Capsule Pregabalin 150mg and Group C will receive Saccharin pill as Placebo.201 patients posted for surgery under General Anaesthesia will be equally divided into these three groups as 67 each.The study will be conducted in Shri B M Patil Medical College,Vijayapura,Karnataka.The primary outcome is to compare the efficacy of two doses of Pregabalin in preventing Succinylcholine induced fasciculations and myalgia in patients undergoing surgery under General Anaesthesia.The secondary outcome is to compare the hemodynamic stability and 24 hour post operative analgesic requirement of the patients who received Pregabalin and the patients who received only Placebo.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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 undergoing surgery under General Anaesthesia.
  • ASA grade 1 or 2.

排除标准

  • Patients with drug allergies Seizure history Cardiac diseases Impaired kidney or Liver function Raised intracranial pressure or intraocular pressure Patients on Antiepileptics,antidepressants,calcium channel blockers Pregnant and Lactating Females.

结局指标

主要结局

To compare the efficacy of two doses of Pregabalin in preventing Succinylcholine-Induced fasciculations and myalgia

时间窗: 2 hours

次要结局

  • To compare the hemodynamic stability and 24 hour post operative analgesic requirement of the patients who received Pregabalin and the patients who received only Placebo(24 hours)

研究者

申办方类型
Private medical college

研究点 (1)

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