Impact of an Opioid Free Anesthesia Protocol Compared to Multimodal Anesthesia on Postoperative Morphine Consumption in an Enhanced Recovery After Gastric Bypass Surgery Protocol: a Prospective, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Total Morphine consumption
研究概览
简要总结
Opioid free anesthesia is a recent anesthesia technique with the aim to avoid peroperative use of morphinics to allow a diminution of secondary morphinics effects in the postoperative period.
There is no robust data on the real benefits of such procedures. Obese patients are particular at risk of secondary effects of opioids. The aim of our study is to compare opioid free anesthesia to multimodal anesthesia on postoperative morphine consumption after a laparoscopic gastric bypass.
详细描述
The aim of the study is to study the impact of an opioid free anesthesia protocol on the postoperative morphine consumption in laparoscopic gastric bypass compared to a multimodal anesthesia protocol.
183 morbidly obese patients (Body mass index >40Kg/m2 or >35kg/m2 AND/OR diabete mellitus AND/OR sleep apnea syndrome AND/OR arterial hypertension.
A randomization will allocate two groups of 100 patients in:
- Group 1: Multimodal anesthesia without opioids
- Group 2: Multimodal anesthesia with opioid The patient, the anesthesist and the data evaluator will be all blinded about the allocation of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •American Society of anesthesia score (ASA) 2-3
- •Scheduled for a laparoscopic gastric bypass surgery
排除标准
- •Patient refusal
- •Medical diseases: Cardiac arrhythmia like atrioventricular block 2nd or 3rd degree, pacemaker, arterial hypotension, severe bradycardia, cerebrovascular pathology, renal and/or hepatic insufficiency
- •Previous bariatric surgery
- •Allergy to any medication used during the surgery
研究组 & 干预措施
Opioid free anesthesia
Dexmedetomidine 0,5 microgrammes/kg of ideal body weight (IBW) + magnesium 40 mg/kg of total body weight (TBW) in 10 minutes
- Dexmedetomidine 0,4- 0,8 microgrammes/kg of IBW/h;Lidocaine 2% 49ml+ Ketamine 50mg: 1ml/10kg of IBW/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ KgTBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;dexmedetomidine: 0,4-0,8 microgramme/kg/h;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence
- Stop dexmedetomidine;Stop sevorane;1 ml of NaCL 0,9%;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Lidocaïne 2% 49ml + Ketamine 50 mg: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Multimodal anesthesia
magnesium 40 mg/kg of total body weight (TBW) in 10 minutes
- Remifentanil 0,2-0,4 microgrammes/kg/min of ideal body weight; Saline 0,9%: Infusion at 1ml/10kg of ideal body weight/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ Kg TBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;remifentanil 0,2-0,4 microgrammes/kg/min;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence
- Stop remifentanil;Stop sevorane;1 ml of morphine 10mg/ml;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Salne 50ml: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours
干预措施: Remifentanil (Drug)
结局指标
主要结局
Total Morphine consumption
时间窗: 24 hours after surgery
total morphine consumption from the PACU arrival to the 24 h post-surgery
次要结局
- Morphine consumption(Post Anesthesia Care Unit admission (Hour 0), Hour +4)
- Quality of Recovery 40 score(operative Day -1, Operative day +1, operative day +30)
- Postoperative Nausea and vomiting(Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24)
- Visual analog scale(Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24)
- Need of Antiemetics(Up to patient discharge)
- Hypoxemia(up to patient discharge)
- Bradycardia and use of atropine(Up to patient discharge)
- Readmissions rate(Up to 30 days)
研究者
matthieu clanet
Head of anesthesia department
Chirec