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临床试验/CTRI/2025/05/087495
CTRI/2025/05/087495尚未招募不适用

Evaluating post operative outcomes with opioid free versus opioid inclusive general anaesthesia for elective surgeries : A randomized clinical trail

Akansha lata1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年6月21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
45
试验地点
1
主要终点
Primary outcome

研究概览

简要总结

Opioid free anaesthesia is a technique where the intraoperative use of systematic , neuraxial or intracavitary opioid is completely eliminated . restricting opioid use in anaesthesia has shown variable effectiveness in different surgeries and patient population . whereas on one hand , the opioid consumption is reduced intraoperatively, effective nociception and reduction in postoperative opioid consumption is still under investigation with OFA.

The commonly used armamentarium of non opioid analgesia includes local anaesthetics , clonidine , dexmedetomidine, ketamine , gabapentin , magnesium sulphate and dexamethasone

The spectrum of opioid free anaesthesia can be of prime utility in patient at high risk of opioid related respiratory complication such as patient with obstructive sleep apnoea , patient posted for bariatric surgeries and patient with pulmonary limitation including obstructive airway diseases

Opioid free anaesthesia also offer particular advantages in opioid tolerant patient such as patient with chronic pain , cancer related pain and patient suffering from opioid addiction .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
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

  • Aged greater than 18 years Booked for elective laparoscopic or superficial surgeries American Society of Anaesthesiologists physical status grade I-II Surgeries lasting less than 3 hrs.

排除标准

  • Pregnant women Body Mass Index greater than 35 Allergy to opioids Allergy to adjuvant drugs Persistent opioid use Non elective surgery Surgeries lasting more than 3 hrs.

结局指标

主要结局

Primary outcome

时间窗: Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

Pain parameters

时间窗: Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

Postoperative pain scores VAS scores (0-10)

时间窗: Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

2nd hr

时间窗: Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

8th hr

时间窗: Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

24hr

时间窗: Primary outcome | Pain parameters | Postoperative pain scores VAS scores (0-10) | 2nd hr | 8th hr | 24hr

次要结局

  • Secondary outcomes(PONV)

研究者

发起方
Akansha lata
申办方类型
Other [self]

研究点 (1)

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