跳至主要内容
临床试验/CTRI/2025/06/089623
CTRI/2025/06/089623招募中不适用

Comparing the Effect of Intraoperative Opioid Sparing Effect of Opioid-free Anaesthesia vs Opioid Anaesthesia on post operative Rescue Analgesic consumption in cardiac surgeries: A Prospective Randomized Study

Kiranmuthrajah1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年7月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
126
试验地点
1
主要终点
Total dosage of rescue analgesic usage - Post extubation in ICU

研究概览

简要总结

This prospective randomised study was conducted to compare the intraoperative opioid-free anaesthesia versus conventional opioid-based anaesthesia on postoperative rescue analgesic consumption in patients undergoing cardiac surgery. Patients scheduled for elective cardiac procedures were randomly assigned to receive either an opioid free anaesthesia regimen-utilising non opioid agents such as dexmedetomedine, ketamine, lignocaine and paracetamol or standard opioid basal protocol. The outcomes was measure as total postoperative rescue analgesic requirement within the first 24 hours after surgery and evaluation of pain scores, hemodynamic stability, incidence of opioid related side effects. The study aimed to determine whether OFA could effectively reduce postoperative analgesic needs while maintaining adequate pain control and hemodynamic safety in cardiac surgical patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 18 years of age or older 2.Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy.

排除标准

  • Patients were excluded in case of emergent or redo surgeries
  • Patients with history of COPD.
  • Patients with known pulmonary Hypertension
  • Patients with EF less than 40% in Echocardiography
  • Patients with significant history of smoking addiction
  • Body mass index more than 35 kg/ m2
  • Obstructive sleep apnea
  • Patient Refusal.

结局指标

主要结局

Total dosage of rescue analgesic usage - Post extubation in ICU

时间窗: Post operative time 0 minutes / 30 minutes / 1 hour / 2 hour / 4 hour / 8 hour / 10 hour / 12 hour / 14 hour / 16 hour / 18 hour / 20 hour / 22 hour / 24 hour | Post operative day 0 / 1 / 2

次要结局

  • 1.Time from discontinuation of inhalation anaesthetic to time of extubation(2.VAS score on POD 1 / 2 / 3)

研究者

发起方
Kiranmuthrajah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kiran Muthu Rajah

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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