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

Phase 3

Completed

• Conditions: Post Operative Nausea and Vomiting; Morbid Obesity; Sleeve Gastrectomy
• Interventions: Drug: Gabapentin; Drug: Ondansetron 8mg

• Registration Number: NCT05620641
• Lead Sponsor: Tanta University

Brief 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.

Detailed 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,

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-17
• Primary Completion: 2025-02-28
• Status Verified: 2025-04
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Gabapentin	include 50 patients scheduled for sleeve gastrectomy
Group 1	Ondansetron 8mg	include 50 patients scheduled for sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study will be the complete response within the first 48 h after surgery.	The first 48 hours after surgery.	Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy

Secondary Outcome Measures

Name	Time	Method
change in the level of the biological parameter dopamine	The first 48 hours after surgery.	5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine
change in the level of the biological parameter substance p	The first 48 hours after surgery.	5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p
change in the level of the biological parameter Serotonin	The first 48 hours after surgery.	5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin
change in the level of the biological parameter vasopressin	The first 48 hours after surgery.	5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin
change in the level of the biological parameter Tachykinin 1	The first 48 hours after surgery.	5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1

Trial Locations

Locations (1)

Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt; 🇪🇬 Tanta, Gharbiya, Egypt