Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery

Phase 3

Completed

Conditions: Opioid Use, Unspecified
Bariatric Surgery Candidate
Anesthesia

Interventions: Drug: Opioid Anesthetics
Drug: Non Opioid Analgesics

Registration Number: NCT04081545

Lead Sponsor: Christine Oryhan

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 181

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Goup A- Opioid-based regimen	Opioid Anesthetics	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 Group B- Opioid-free regimen	Non Opioid Analgesics	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

Primary Outcome Measures

Name	Time	Method
24 Hour Opioid Consumption	24 hours	Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses

Secondary Outcome Measures

Name	Time	Method
Length of Time Under General Anesthesia	1-5 hours	Time from induction to emergence of anesthesia
Percentage of Patients With Opioid-related Adverse Effects	24 hours	Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome.
Length of Time to Recover From General Anesthesia	1-3 hours	Time from arrival to PACU to "ready for PACU discharge"
Length of Hospital Stay	1-5 days	Time from PACU arrival to discharge date and time in days
Overall Patient Satisfaction With Analgesia: Yes or no	24 hours	Number of Participants With Overall Patient Satisfaction With Analgesia
Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days	30 days	Number of participates with opioid prescription refills since surgery within 30 day after surgery
Percentage of Patients Treated for General Anesthetic Adverse Effects	Intraoperative, between time entering OR and PACU arrival time	Episodes of severe bradycardia or treated hypotension intraoperatively
Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery	3 months	Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery