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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2023-06-30

Brief Summary

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A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.

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Detailed Description

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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.

Conditions

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Opioid Use, Unspecified Bariatric Surgery Candidate Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators plan to enroll 196 subjects at Virginia Mason Medical Center that are undergoing laparoscopic bariatric surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm, with a computer generated arm assignment. Subjects will be blinded to the assigned arm. Group A will receive a traditional opioid restrictive general anesthetic and group B will receive an opioid-free anesthetic technique.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Opioid Anesthetics

Intervention Type DRUG

see arm/group description

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

Group Type EXPERIMENTAL

Non Opioid Analgesics

Intervention Type DRUG

see arm/group description

Interventions

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Opioid Anesthetics

see arm/group description

Intervention Type DRUG

Non Opioid Analgesics

see arm/group description

Intervention Type DRUG

Other Intervention Names

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Opioid-based regimen Opioid-free regimen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes