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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620641
• Other study ID #: 35647
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Aya Moussa, assistant lecturer
• Phone: 01222607803
• Email: aya.mosa[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Nausea
• Obesity, Morbid
• Post Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Sleeve Gastrectomy
• Vomiting

Intervention

Drug:
• Ondansetron 8mg
50 patients will receive intravenous ondansetron 8 mg before the end of surgery.
• Gabapentin
50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

Locations

Country	Name	City	State
Egypt	Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.