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

Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Post Operative Nausea and Vomiting; Sleeve Gastrectomy
• Intervention / Treatment: Drug: Ondansetron 8mg; Drug: Gabapentin

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31111
      • Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; include 50 patients scheduled for sleeve gastrectomy	Drug: Ondansetron 8mg; 50 patients will receive intravenous ondansetron 8 mg before the end of surgery.; Other Names: zofran
Experimental: Group 2; include 50 patients scheduled for sleeve gastrectomy	Drug: Gabapentin; 50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the level of the biological parameter vasopressin	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	The first 48 hours after surgery.
change in the level of the biological parameter dopamine	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	The first 48 hours after surgery.
change in the level of the biological parameter substance p	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	The first 48 hours after surgery.
change in the level of the biological parameter Serotonin	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	The first 48 hours after surgery.
change in the level of the biological parameter Tachykinin 1	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	The first 48 hours after surgery.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; ondansetron; Laparoscopic Sleeve Gastrectomy; gabapentine
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Signs and Symptoms, Digestive; Overweight; Obesity; Nausea; Vomiting; Postoperative Nausea and Vomiting; Obesity, Morbid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Gabapentin; Ondansetron
• Other Study ID Numbers: 35647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No