Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516953
• Other study ID #: 35647/8/22
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 22, 2022
• Est. completion date: August 2024

Study information

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

Clinical Trial 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.

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

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:

• 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

• Laparoscopic Sleeve Gastrectomy
• Morbid Obesity
• Nausea
• Obesity, Morbid
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Baclofen Tablets
10 mg oral baclofen 1 h before anesthesia

Locations

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

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	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 serum level of vasopressin	Blood samples will be collected at baseline, 24 hours and 48 hours after surgery	The first 48 hours after surgery.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.