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

Ketamine

Brief Summary

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

Intervention / Treatment

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.
  • Opioid Anesthetics (DRUG)
    see arm/group description
  • Non Opioid Analgesics (DRUG)
    see arm/group description

Condition or Disease

  • Opioid Use, Unspecified
  • Bariatric Surgery Candidate
  • Anesthesia

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 184 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Dec 24, 2019 ACTUAL
    Primary Completion: Mar 29, 2023 ACTUAL
    Completion Date: Jun 30, 2023 ESTIMATED
    Study First Posted: Sep 09, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 06, 2023

    Sponsors / Collaborators

    Lead Sponsor: Christine Oryhan
    Responsible Party: Christine Oryhan

    Location

    Seattle, Washington, USA

    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.

    Participant Groups

    • 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

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Total amount of opioid use within the first 24 hours after surgery in morphine equivalent doses

    Secondary Outcomes

    • The Numeric Rating Scale (NRS) for evaluating level of pain. The rating is verbal, and the subject is asked to estimate current pain intensity on an 11-point scale, where 0 indicates no pain at all and 10 the worst imaginable pain. This will be performed in the PACU, within first 24 hours after surgery, at 30 day follow-up phone call and at 3 month follow-up visit

    • Time from induction to emergence of anesthesia in minutes

    • Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression

    • Time to diet advancement to full liquid diet and time to first bowel movement

    • Time from arrival to PACU to "ready for PACU discharge" in minutes

    • Time from PACU arrival to discharge date and time in hours

    • Satisfaction with overall post-operative pain control (yes or no)

    • Number of opioid prescription refills since surgery to be assessed at 30 day follow-up phone call and 3 month follow-up visit

    • Adverse effects include hypotension, bradycardia, nausea, vomiting

    More Details

    NCT Number: NCT04081545
    Other IDs: CRP19060
    Study URL: https://clinicaltrials.gov/study/NCT04081545
    Last updated: Sep 29, 2023