Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Last updated: April 16, 2025
Sponsor: Tanta University
Overall Status: Completed

Phase

3

Condition

Vomiting

Colic

Obesity

Treatment

Gabapentin

Ondansetron 8mg

Clinical Study ID

NCT05620641
35647
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Both male and female patients will be included.

  • 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): 2
Primary Treatment: Gabapentin
Phase: 3
Study Start date:
October 01, 2022
Estimated Completion Date:
April 01, 2025

Study Description

This study will be a double blind randomized, controlled, parallel, study. A total of1 00 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 two groups by closed envelop method,

Connect with a study center

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

    Tanta, Gharbiya 31111
    Egypt

    Site Not Available

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