Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Tanta University

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Laparoscopic Sleeve Gastrectomy

Postoperative Nausea and Vomiting

Morbid Obesity

Treatments

Drug: Baclofen Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT05516953

35647/8/22

Details and patient eligibility

About

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.

Full 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

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
Patients fit for anesthesia and surgery.

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 hours before 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 this study.