Comparison between opioid free Anesthesia and opioid based anaesthesia for patients undergoing laparoscopic surgeries under general anaesthesia. A double blinded randomized control trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the heart rate and mean arterial pressure intraoperative with continuous lidocaine and dexmedetomidine infusion as opposed to conventional opioid based anaesthesia
研究概览
简要总结
Opioid free anaesthesia is the use of multimodal or balanced analgesia,the principle is to gain additive analgesic effects from different drugs while minimising side effects, particularly those of opioids.studies have shown that opioid free anaesthesia fast tracks surgery,reduces hospital stay, early mobilization and enteral nutrition.
The current study is planned to compare the analgesic and sedative effects of opioids (fentanyl) with opioid free drugs (lidocaine and dexmedetomidine)during perioperative period and to compare recovery characteristics and hemodynamics (heart rate and mean arterial pressure)as secondary outcome.
Inorder to provide adequate perioperative pain management the over use and over prescription of opioids have contributed to opioid crisis. Reports indicate that the number of overdose deaths from prescription and illicit opioids have quadrupled since 2000 from opioid addiction.
Improper opioid use , unsecure opioid storage and lack of appropriate disposal of unused or expired opioids increase the availability of these drugs for others to abuse and are major contributors to current opioid crisis . To overcome this FDA and department of justice drug enforcement administration have uniform guidelines regarding using ,storing and not sharing with others.FDA recommend that opioids are best disposed via medicine take back programs.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA physical status 1 and 2 2.Age between 18 to 65 years 3.Patients undergoing laparoscopic surgeries under general anaesthesia.
排除标准
- •1.History of opioid use 1 month prior to surgery 2.chronic opioid addiction 3.Inability to comprehend visual analogue scale 4.history of significant hepatic renal and cardiac disease 5.history of chronic pain and drug abuse.
结局指标
主要结局
To compare the heart rate and mean arterial pressure intraoperative with continuous lidocaine and dexmedetomidine infusion as opposed to conventional opioid based anaesthesia
时间窗: 24 hours
次要结局
- 1.postoperative pain in first 24 hours and time to rescue analgesia is compared in both groups(2.postoperative nausea vomiting assessment in both groups)