COMPARISON OF OPIOID FREE ANAESTHESIA AND CONVENTIONAL GENERAL ANAESTHESIA IN PATIENTS UNDERGOING LAPROSCOPIC CHOLECYSTECTOMY – A PROSPECTIVE RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the intraoperative need to administer opioids for adequate intraoperative analgesia.
研究概览
简要总结
Opioid free anaesthesia is a technique of providing anaesthesia by combining intravenous administration of a combination of non opioid agents to produce adequate intraoperative analgesia, hypnosis, sympatholysis and pain free awakening. Although opioid analgesics have been the mainstay of conventional general anaesthesia due to their analgesic effect, they are also associated with respiratory depression, gastrointestinal symptoms, urine retention, psychological deficiencies, inflammation modulation & immune depression. To the best of our knowledge, there is paucity of comprehensive data on the feasibility and effectiveness of opioid free anaesthesia in laproscopic surgeries. hence we propose this study to report on the feasibility, efficacy and quality of recovery with an adapted opioid free anaesthesia protocol in subjects undergoing elective laproscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •ASA grade I and II
- •BMI -18-25
- •Undergoing laparoscopic cholecystectomy
- •Written informed consent.
排除标准
- •â€¢history of allergy to any drug used for OFA or CGA; •history of alcohol, opioid or drug abuse; •chronic pain •psychiatric illness; •patients undergoing surgery with planned regional anesthesia, •patients with iatrogenic surgical complications such as bowel, ureter or bladder injuries.
- •â€¢Duration of surgery exceeding 90 minutes.
- •â€¢pregnancy.
结局指标
主要结局
the intraoperative need to administer opioids for adequate intraoperative analgesia.
时间窗: 1) INTRAOPERATIVE | 2) POSTOPERATIVE TILL 48 HRS AFTER THE SURGERY
次要结局
- 1. Occurrence of intra-operative complications e.g. hypotension, hypertension, tachycardia and bradycardia.(2. Mean alveolar concentration (MAC in %) of isoflurane used in both groups.)