The Effect of an Opioid-free Anesthetic on Post-operative Opioid Consumption After Laparoscopic Bariatric Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- 24 Hour Opioid Consumption
研究概览
简要总结
A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.
详细描述
This is a prospective, single-center, single-blinded, randomized controlled trial comparing the effect of an opioid-free general anesthetic versus a traditional anesthetic with a restricted quantity of opioid on postoperative opioid consumption following laparoscopic bariatric surgery. The study population will be composed of 196 subjects undergoing laparoscopic bariatric surgery at Virginia Mason Medical center randomized into two groups. The control group will receive a traditional opioid restrictive general anesthetic. The study group will receive an opioid-free anesthetic technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent
排除标准
- •Any opioid use within 4 weeks prior to surgery
- •Chronic antiemetic use
- •Conversion of laparoscopic to open surgery
- •Patients unable to provide post-operative pain scores
- •Pregnant or lactating patients
- •Patients under 18 years of age
- •Refusal or inability to provide informed consent
研究组 & 干预措施
Control Goup A- Opioid-based regimen
Preop - Multimodals unless contraindicated
Induction
- Fentanyl (50mcg IV)
- Lidocaine 1.5mg/kg IV bolus using IBW (Ideal body weight)
- Propofol 2-3mg/kg IV bolus
- Neuromuscular blockade per Anesthesiology team discretion
Maintenance
- Sevoflurane
- Neuromuscular blockade at discretion of anesthesiology team
- May use fentanyl to treat SBP or HR > 20% of baseline
Emergence
- Neuromuscular reversal, dosed according to Virginia Mason protocol
- May titrate fentanyl per anesthesiology team throughout the case.
- Patient extubated and brought to PACU
PACU opioid orders per anesthesiology team
Post-operative Nausea/Vomiting Prophylaxis
-4mg dexamethasone, 1mg haloperidol, scopolamine patch
干预措施: Opioid Anesthetics (Drug)
Experimental Group B- Opioid-free regimen
Preop - Multimodals unless contraindicated
Induction
- Dexmedetomidine 1mcg/kg IV bolus over 10 minutes using IBW
- Lidocaine 1.5mg/kg IV bolus using IBW
- Propofol 2-3mg/kg IV bolus
- Neuromuscular blockade per Anesthesiology team discretion
- Ketamine 0.5mg/kg IV bolus (based on IBW)
Maintenance
- Sevoflurane
- Dexmedetomidine 0.4 mcg/kg/hr IV infusion using IBW (may titrate based on patient response between 0.3-0.5mcg/kg/hr)
- Lidocaine 2mg/kg/hr IV infusion using IBW
- May use esmolol as needed to treat SBP or HR > 20% of baseline
- Neuromuscular blockade at the discretion of anesthesiology team
Emergence
- Dexmedetomidine infusion turned off during laparoscopic desufflation
- Lidocaine infusion turned off at skin closure
- Neuromuscular reversal, dosed according to VM protocol
- Pt extubated and brought to PACU
- PACU opioid orders per anesthesiology team
Post-operative Nausea/Vomiting Prophylaxis
-4mg dexamethasone, 1mg haloperidol, scopolamine patch
干预措施: Non Opioid Analgesics (Drug)
结局指标
主要结局
24 Hour Opioid Consumption
时间窗: 24 hours
Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses
次要结局
- Length of Time Under General Anesthesia(1-5 hours)
- Percentage of Patients With Opioid-related Adverse Effects(24 hours)
- Length of Time to Recover From General Anesthesia(1-3 hours)
- Length of Hospital Stay(1-5 days)
- Overall Patient Satisfaction With Analgesia: Yes or no(24 hours)
- Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days(30 days)
- Percentage of Patients Treated for General Anesthetic Adverse Effects(Intraoperative, between time entering OR and PACU arrival time)
- Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery(3 months)
研究者
Christine Oryhan
Anesthesiologist and Pain Medicine Physician
Benaroya Research Institute