Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery

Ketamine

Brief Summary

Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases. Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication. Our study hypothesis is that different types of anesthetics reduce PONV further. Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA). The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.

Intervention / Treatment

  • TIVA NoNarc (DRUG)
    * patients in both groups receive antiemetic prophylaxis * patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively * postop management in both groups is similar in both groups

Condition or Disease

  • Postoperative Nausea and Vomiting

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 124 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Nov 01, 2011
    Primary Completion: Oct 01, 2012 ACTUAL
    Completion Date: Oct 01, 2012 ACTUAL
    Study First Posted: Oct 10, 2011 ESTIMATED
    Results First Posted: Mar 21, 2016 ESTIMATED
    Last Updated: Feb 19, 2016

    Sponsors / Collaborators

    Lead Sponsor: Coastal Anesthesiology Consultants
    Responsible Party: N/A

    Location

    St. Augustine, Florida, USA

    See above

    Participant Groups

    • Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.

    • Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine

    Eligibility Criteria

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

    Inclusion Criteria:

    * All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.

    Exclusion Criteria:

    * Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.

    Primary Outcomes

    • Postoperative Nausea and Vomiting

    Secondary Outcomes
    • Number of Patients Requiring Antiemetic Rescue Medication (AERM) 24hours
    • PONV Between Different Surgical Procedures (Percentage of Participants) 24 hours

    More Details

    NCT Number: NCT01449708
    Other IDs: 3766 - 6886
    Study URL: https://clinicaltrials.gov/study/NCT01449708
    Last updated: Sep 29, 2023