Opioid Free Anesthesia and Bariatric Surgery

Ketamine

Brief Summary

The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.

Intervention / Treatment

  • Opioid Free Total Intravenous Anesthesia (COMBINATION_PRODUCT)
    Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
  • Total Intravenous anesthesia with opioid (COMBINATION_PRODUCT)

Condition or Disease

  • Postoperative Quality of Recovery

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 58 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 09, 2021 ACTUAL
    Primary Completion: Mar 29, 2024 ESTIMATED
    Completion Date: Mar 29, 2024 ESTIMATED
    Study First Posted: Oct 30, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 25, 2023

    Sponsors / Collaborators

    Lead Sponsor: Northwell Health
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Manhasset, New York, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA I-III
    * Non-pregnant
    * Undergoing laparoscopic bariatric surgery for weight loss.

    Exclusion Criteria:

    * Unable to obtain informed consent or consent withdrawn.
    * Patients who are pregnant or nursing.
    * ASA IV-V
    * Alcohol or narcotic misuse or dependence in the last 2 years.
    * Preoperative daily opioid use for one year for pain management.
    * Egg or soy product allergy
    * Active liver disease
    * Patients with left ventricular assist devices
    * Abnormal renal function
    * Any contraindication to any opioid or non-opioid pain analgesics
    * Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).

    Secondary Outcomes

    • Postoperative pain intensities using a 0 to 10 numerical rating scale (NRS) with higher scores indicative of higher pain intensities.

    • Total postoperative opioid consumption

    • Time to post-anesthesia care unit discharge readiness

    Other Outcomes

    • The incidence of any postoperative nausea, retching, or vomiting.

    More Details

    NCT Number: NCT04144153
    Other IDs: 19-0728
    Study URL: https://clinicaltrials.gov/study/NCT04144153
    Last updated: Sep 29, 2023