Comparison of analgesic efficacy of keto-dex versus keto-lig as opioid sparing maintenance analgesics in patient undergoing laparoscopic incisional hernia under entropy guided general anaesthesia: A randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- To compare intraoperative fentanyl consumption between two groups
研究概览
简要总结
Opioid have been the main stay to provide analgesia for surgeries. These are however associated with numerous side effects varying from simple delayed recovery to precarious complication like respiratory depression, post operative nausea vomiting. Opioid sparing maintenance analgesia (OSMA) which include non opioid analgesics has now emerged as a feasible and safe alternative to the conventional opioid based general anaesthesia. The drug most commonly used for non opioid analgesics are dexmedetomidine, ketamine, lignocaine ,MgSO4,dexamethasone and paracetamol. Previous studies have proved that this non opioid analgesics are equally efficacious to opioid and can be alternative to opioids. In previous studies, those used either single drug infusion or combination drug (for example., ketamine and dexmedetomidine) showed they are equally efficacious to fentanyl and can be used as an alternative to opioid. But there is no study comparing the combination of non opioid analgesics. So we thought to conduct a study comparing the combination of non opioid analgesics under entropy guided monitoring. We will divide all the recruited patient into three groups keto-dex, keto-lig and control groups. For keto-dex group(ketamine:0.2mg/kg/hours+ dexmedetomidine :0.5 microgram/kg/hour) and for keto-lig group (ketamine:0.2mg/kg/hour + lignocaine: 1 mg/kg/hour) and for control group normal saline infusion will be started immediately after intubation for maintenance analgesia in intraoperative period with entropy monitoring. Extra doses of fentanyl (0.5mcg/kg) bolus will be given to every patients under entropy guided monitoring and if the difference between response entropy(RE )and state entropy(SE) exceed more than 10 and will be noted in every patients in all group. In the postoperative period rescue analgesia will be done by fentanyl and noted. In the postoperative period assessment of pain will be done by VAS, recovery by modified Aldrete’s score, sedation by Ramsay sedation score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor 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
- •1.Age 18 years to 60 years 2.American Society of Anaesthesiologists (ASA) physical status 1 and 2 3.Undergoing elective laparoscopic incisional hernia under general anesthesia.
排除标准
- •1.Presence of any uncontrolled cardiovascular disease (hypertension, conduction block etc) 2.Presence of any cerebrovascular or neurological disease (seizure, past history of stroke etc) 3.Patient on any anti-psychotic drugs or antidepressant drugs 4.Patient on beta blocker 5.Presence of any chronic liver or kidney disease 6.Pregnant and nursing women 7.Surgery duration more than 3 hours 8.BMI more than 35 KG/M2.
结局指标
主要结局
To compare intraoperative fentanyl consumption between two groups
时间窗: 15 minutes,30 minutes,45 minutes,60 minutes,90 minutes,120 minutes, 150 minutes post intubation
次要结局
- Intra- operative haemodynamic(5 minute, 10 minute, 15 minute, 30 minute ,45 minute, 60 minute, 90 minute,120 minute 150 minute)
- Post operative analgesia requirements(15 min, 30 min, 1 hour,2hours,4hours,8hours,12hours)
- Post operative sedation score(15 min, 30 min, 1 hour,2hours,4hours,8hours,12hours)
- Recovery time(postoperative period)
- Post operative nausea & vomiting(Numeber of episodes in postoperative period)