Quality of Recovery After Laparoscopic Cholecystectomy: A Prospective, Randomised, Controlled Trial Comparing Opioid Free Multimodal Analgesia Versus Opioid Based Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality of recovery
研究概览
简要总结
The aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale (QoR-15) for participant's receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy.
详细描述
Type of Study: interventional, randomized and double-blinded controlled trial. Study Setting: The operating theatres of Ain Shams University Hospitals. Study Period: over one year.
Study Procedures
Patients will be randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the two groups according to the used analgesia into:
o Group Traditional balanced anesthesia (TBA): Analgesia will be provided by fentanyl in induction and maintenance according to Ideal Body Weight (IBW)
o Group Opioid free anesthesia (OFA): Analgesia will be provided by syringe containing ketamine, Lidocaine and Dexmedetomidine in induction and maintenance according to lean body weight (LBW).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Pregnant or breast-feeding women
- •ASA physical status class > 2
- •The need to change laparoscopic surgery to an open one
- •Allergy to any of the drugs used in the study
- •local skin infection at the trocar injection site
- •1st or 2nd degree Heart block
- •Chronic treatment by beta-blockers
- •HR <50 bpm
- •Epilepsy or seizures
- •Alcohol or drug abuse
- •Psychiatric disease
- •History of chronic pain
研究组 & 干预措施
Opioid free anesthesia (OFA) group
Analgesia will be provided by syringe containing ketamine, Lidocaine and Dexmedetomidine in induction and maintenance according to lean body weight (LBW).
Induction :
Ketamine: 0.5 mg/kg (IBW), Lidocaine 1 mg/kg and dexmedetomidine 0.5 mg/kg (LBW) for induction to be given in 10 ml syringe over 10 minutes.
Maintenance : The maintenance mixture" - 50 cc syringe containing:
50 mcg Dexmedetomidine (0.5 cc of standard 100 mcg/ml solution) 50 mg Ketamine 500 mg Lidocaine (25 ml of standard 2% solution) NaCl up to total 50 ml
干预措施: Opioid free analgesia (Drug)
Opioid based anesthesia( OBA )group
Fentanyl 2 g/kg (LBW) as induction dose in 10 ml syringe to be given over 10 minutes, and 1 g/kg/h in 50 ml syringe as infusion during operation starting before skin incision for Group TBA.
干预措施: Opioid based Anesthesia (Drug)
结局指标
主要结局
Quality of recovery
时间窗: 24 hour
The 15-item quality of recovery (QoR-15) score at 24 h postoperatively. o The QoR-15 score : is a shorter validated version of the QoR-40 and provides an efficient evaluation of post-operative recovery from the participant's perspective with total QoR-15 score ranging from 0 (extremely poor recovery) to 150 (excellent recovery).(Stark et al.,2013) Each question is measured on a Likert scale ranging from 0-10; where 0 = none of the time \[poor\] to 10 = all of the time \[excellent\]. Results are considered clinically significant if there is a change of score of eight.
次要结局
- Post operative pain(24 hour)
- Postoperative bradycardia(24 hour)
- Postoperative hypertension(24 hour)
- Postoperative Hypoxia(24 hour)
- Postoperative nausea and vomiting(24 hour)
- Postoperative hypotension(24 hour)