The Effect of an Opioid-free Anesthetic on Post-operative Opioid Consumption After Laparoscopic Bariatric Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Opioid Anesthetics
- Conditions
- Anesthesia
- Sponsor
- Christine Oryhan
- Enrollment
- 181
- Locations
- 1
- Primary Endpoint
- 24 Hour Opioid Consumption
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.
Detailed Description
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.
Investigators
Christine Oryhan
Anesthesiologist and Pain Medicine Physician
Benaroya Research Institute
Eligibility Criteria
Inclusion Criteria
- •Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Opioid Anesthetics
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
Intervention: Non Opioid Analgesics
Outcomes
Primary Outcomes
24 Hour Opioid Consumption
Time Frame: 24 hours
Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses
Secondary Outcomes
- 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)