Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Postoperative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Drug: Baclofen Tablets

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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
No Intervention: Group 1(Control group); include 50 patients scheduled for sleeve gastrectomy
Experimental: Group 2; which include 50 patients scheduled for sleeve gastrectomy	Drug: Baclofen Tablets; 10 mg oral baclofen 1 h before anesthesia; Other Names: baclofen

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	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 serum level of vasopressin	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery	The first 48 hours after surgery.
Change in serum level of substance P	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery	The first 48 hours after surgery.
Change in serum level of dopamine	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery	The first 48 hours after surgery.
Change in serum level of serotonin	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery	The first 48 hours after surgery.
Change in serum level of tachykinin 1	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery	The first 48 hours after surgery.

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Aya Moussa, Faculty of Pharmacy Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): December 28, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Morbid Obesity; Postoperative Nausea and Vomiting; baclofen; Laparoscopic Sleeve Gastrectomy
• 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; Peripheral Nervous System Agents; Neurotransmitter Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: 35647/8/22

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