Ketamine in Bariatric Surgery

Ketamine

Brief Summary

Ketamine may improve recovery from bariatric surgery.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • Fentanyl (DRUG)
    N/A

Condition or Disease

  • Morbid Obesity

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 90 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2012
    Primary Completion: Jun 01, 2014 ESTIMATED
    Completion Date: Jun 01, 2014 ESTIMATED
    Study First Posted: Nov 12, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 07, 2012

    Sponsors / Collaborators

    Lead Sponsor: University of Padova
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Padua, Veneto, Italy

    Participant Groups

    • patients will receive ketamine at induction

    • patients will receive fentanyl at induction

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * age \> 18
    * obesity (Body Mass Index \> 30)
    * ASA classificazion \< 4
    * candidate to bariatric surgery

    Exclusion Criteria:

    * known or presumed pregnancy
    * previous surgery on the airway, esophagus or stomach
    * uncontrolled psychiatric symptomatology

    Primary Outcomes
    • pain level postoperatively, up to 3 months
    • mood level postoperatively, up to 3 months
    Secondary Outcomes
    • total dosages of analgesic and muscle relaxant drugs postoperatively, up to 3 months
    • postanesthetic recovery postoperatively, up to 24 hours
    • satisfaction of the patient and of the surgeon day 1
    • pulse oximetry saturation postoperatively, up to 24 hours
    • lung volumes postoperatively, up to 48 hours from end of surgery
    • antihemetic drug dosage postoperatively, up to 24 hours
    • vasoactive drugs intraoperatively and up to 24 hours from surgery end

    More Details

    NCT Number: NCT01724983
    Other IDs: KET2271
    Study URL: https://clinicaltrials.gov/study/NCT01724983
    Last updated: Sep 29, 2023