Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Phase 2

Active, not recruiting

• Conditions: Laparoscopic Sleeve Gastrectomy; Postoperative Nausea and Vomiting; Morbid Obesity
• Interventions: Drug: Baclofen Tablets

• Registration Number: NCT05516953
• Lead Sponsor: Tanta University

Brief Summary

This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Detailed Description

. A total of 100 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 four groups by closed envelop method

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2022-08-22
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

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

Inclusion Criteria

• 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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Baclofen Tablets	which include 50 patients scheduled for sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study will be the complete response	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 serum level of vasopressin	The first 48 hours after surgery.	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Change in serum level of serotonin	The first 48 hours after surgery.	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Change in serum level of tachykinin 1	The first 48 hours after surgery.	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Change in serum level of substance P	The first 48 hours after surgery.	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Change in serum level of dopamine	The first 48 hours after surgery.	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery

Trial Locations

Locations (1)

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