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

NCT05620641 | Completed Phase 3

• 1 other identifier: 35647
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Nausea and Vomiting; Sleeve Gastrectomy; Morbid Obesity

Keywords

Postoperative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy; ondansetron; gabapentine

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be the complete response within the first 48 h after surgery.

  Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy

  The first 48 hours after surgery.

Secondary Outcomes (5)

• change in the level of the biological parameter vasopressin

  The first 48 hours after surgery.

• change in the level of the biological parameter dopamine

  The first 48 hours after surgery.

• change in the level of the biological parameter substance p

  The first 48 hours after surgery.

• change in the level of the biological parameter Serotonin

  The first 48 hours after surgery.

• change in the level of the biological parameter Tachykinin 1

  The first 48 hours after surgery.

Study Arms (2)

Group 1

EXPERIMENTAL

include 50 patients scheduled for sleeve gastrectomy

Drug: Ondansetron 8mg

Group 2

EXPERIMENTAL

include 50 patients scheduled for sleeve gastrectomy

Drug: Gabapentin

Interventions

Ondansetron 8mg DRUG

50 patients will receive intravenous ondansetron 8 mg before the end of surgery.

Also known as: zofran

Group 1

Gabapentin DRUG

50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

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

Tanta, Gharbia Governorate, 31111, Egypt

Location

MeSH Terms

Conditions

Vomiting; Obesity, Morbid; Postoperative Nausea and Vomiting

Interventions

Ondansetron; Gabapentin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Clinical Pharmacy department , Faculty of Pharmacy -Tanta University

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 17, 2022
• Study Start: October 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: April 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)