Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Last updated: April 18, 2025
Sponsor: Tanta University
Overall Status: Completed

Phase

2/3

Condition

Stomach Discomfort

Vomiting

Lactose Intolerance

Treatment

Baclofen Tablets

Clinical Study ID

NCT05516953
35647/8/22
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with thepresence of comorbidity such as hypertension, arthritis, and diabetes.

  • Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 withoutcomorbidity.

  • Patients fit for anesthesia and surgery.

Exclusion

Exclusion Criteria:

  • Patients with BMI >55 kg/m2.

  • Patients with previous procedures for the treatment of obesity.

  • Pregnant females and lactating women.

  • Patients with psychological or psychiatric disease

  • Administration of antiemetic medication or systemic corticosteroids within 24 hoursbefore surgery

  • Patients who experienced vomiting within 24 hours before surgery.

  • Patients with history of alcohol or drug abuse.

  • Patients with hypersensitivity or contraindications to any of the drugs used in thisstudy.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Baclofen Tablets
Phase: 2/3
Study Start date:
August 22, 2022
Estimated Completion Date:
February 28, 2025

Study Description

. A total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into four groups by closed envelop method

Connect with a study center

  • Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital.

    Tanta, 31111
    Egypt

    Site Not Available

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