The Effect of an Opioid-free Anesthetic on Post-operative Opioid Consumption After Laparoscopic Bariatric Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent
Locations
United States
Washington
Virginia Mason Medical Center
Seattle
Time Frame
Start Date: 2019-12-24
Completion Date: 2023-06-30
Participants
Target number of participants: 181
Treatments
Active_comparator: 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
Experimental: 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
Authors
Angela Hirsch, Jeffrey Hunter, Alexander Nguyen, Lily Chang, Christine L Oryhan, Nam Nguyen, Mohan Mallipeddi, Josiah Perez, Joseph Strunk, Brett Plancich
Sponsors
Collaborators: Virginia Mason Hospital/Medical Center
Leads: Christine Oryhan