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临床试验/CTRI/2022/11/046967
CTRI/2022/11/046967尚未招募4 期

A randomized comparative study to evaluate recovery profile and hemodynamics of opioid free anesthesia versus standard balanced anesthesia technique for laproscopic cholecystectomy

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年7月11日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
The time taken for extubation between the opioid free anesthesia versus standard balanced anesthesia group

研究概览

简要总结

This study aims to compare Standard Balanced Anesthesia versus Opioid Free Anesthesia technique in laproscopic cholecystectomy.

The Primary objective is comparison of time to extubation in patient of 2 groups.

In the past there are studies comparing the two technique , however no study is directly related to our primary objective.

The patients will be classified into OFA group who will receive Injection Ketamine (bolus) followed by dexmedetomidine infusion & SBA group who will receive Injection Fentanyl (bolus) followed by saline infusion. Further time to extubation & recovery profile of 2 groups will be compared

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •Patients giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • •1.Patients with known case of cardiovascular, pulmonary, psychological or neurological diseases 2.Patients who are known to be epileptic 3.Patients who have signs and symptoms of raised intracranial tension 4.Patients with known allergies to the study drugs 5.Patients with abnormalities like heart block, left bundle branch block 6.Obese patients (BMI ≥ 30kg/m2).

结局指标

主要结局

The time taken for extubation between the opioid free anesthesia versus standard balanced anesthesia group

时间窗: The time to extubation, which is the time taken from the injection of reversal to the extubation of endotracheal tube which will be counted in minutes (the same has been used for sample size calculation as well).

次要结局

  • To compare between the two groups-(1. Hemodynamic parameters at the time of inubation)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college

研究点 (1)

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