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

Tanta University

Status and phase: Completed; Phase 3

Conditions: Post Operative Nausea and Vomiting; Sleeve Gastrectomy; Morbid Obesity

Treatments: Drug: Ondansetron 8mg; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05620641

35647

Details and patient eligibility

About

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.

Full 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,

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Both male and female patients will be included.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group 1

Experimental group

Description:

include 50 patients scheduled for sleeve gastrectomy

Treatment:

Drug: Ondansetron 8mg

Group 2

Experimental group

Description:

include 50 patients scheduled for sleeve gastrectomy

Treatment:

Drug: Gabapentin