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临床试验/CTRI/2024/06/068439
CTRI/2024/06/068439尚未招募2/3 期

COMPARISON OF CONVENTIONAL OPIOID BASED VERSUS OPIOID FREE ANAESTHESIA FOR THE QUALITY OF RECOVERY IN ADULT PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To assess the quality of recovery at 6 hours after the surgery using the QoR-40 score in adult

研究概览

简要总结

This is a comparative, interventional study comparing an opioid based anaesthesia versus and opioid free anaesthesia technique in laparoscopic cholecystectomy surgeries with the primary objective being the comparison of the quality of recovery at 6 hours post surgery and the secondary objectives being the comparison of haemodynamic parameters, emergence time, cortisol levels at baseline and at 6 hours post surgery and the QoR-40 score at 24 hrs.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 18-65 years belonging to American society of Anaesthesiologists (ASA) physical status I -II scheduled to undergo elective laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • Anticipated difficult airway
  • High risk of aspiration
  • Chronic analgesic therapy
  • Local block site infection
  • Previous abdominal surgery and/or chances of converting to open surgery 6.

结局指标

主要结局

To assess the quality of recovery at 6 hours after the surgery using the QoR-40 score in adult

时间窗: At 6 hours after the surgery

patients undergoing laparoscopic cholecystectomy

时间窗: At 6 hours after the surgery

次要结局

  • Intraoperative haemodynamic parameters(During surgery)
  • Emergence time(After the surgery)
  • Time to first rescue analgesia and total amount used(In the post-operative period)
  • Stress hormone levels(At baseline and at 6 hours)
  • Assess the quality of recovery using QoR-40 score(after 24 hrs)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Darshana V

Vardhman Mahavir medical college and Safdarjung hospital

研究点 (1)

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