Sedation of Morbidly Obese for Balloon Insertion

Ketamine

Brief Summary

This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.

Intervention / Treatment

  • Fentanyl (DRUG)
    0.5 mic/kg fentanyl will be given immediately before the procedure
  • Ketamine (DRUG)
    0.25 mg ketamine will be administered immediately before the procedure

Condition or Disease

  • Morbid Obesity

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 20 Years to 45 Years
    Enrollment: 70 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2018 ESTIMATED
    Primary Completion: Mar 20, 2019 ESTIMATED
    Completion Date: Apr 15, 2019 ESTIMATED
    Study First Posted: Nov 20, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 17, 2018

    Sponsors / Collaborators

    Lead Sponsor: Mansoura University
    Responsible Party: N/A

    Location

    Mansoura, Dakahlia, Egypt

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * morbid obese indicated for gastric balloon insertion

    Exclusion Criteria:

    - Refusal Hypersensitivity to any of the study drugs

    Primary Outcomes

    • Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion

    More Details

    NCT Number: NCT03747094
    Acronym: SedBaloon
    Other IDs: Sedation for balloon insertion
    Study URL: https://clinicaltrials.gov/study/NCT03747094
    Last updated: Sep 29, 2023