Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
Overview
- Phase
- Phase 2
- Intervention
- Baclofen Tablets
- Conditions
- Postoperative Nausea and Vomiting
- Sponsor
- Tanta University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The primary outcome of this study will be the complete response
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Aya Gamal Moussa
Assistant Lecturer at Clinical Pharmacy department , Faculty of Pharmacy -Tanta University
Tanta University
Eligibility Criteria
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/m
- •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.
Arms & Interventions
Group 2
which include 50 patients scheduled for sleeve gastrectomy
Intervention: Baclofen Tablets
Outcomes
Primary Outcomes
The primary outcome of this study will be the complete response
Time Frame: 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 Outcomes
- Change in serum level of vasopressin(The first 48 hours after surgery.)
- Change in serum level of serotonin(The first 48 hours after surgery.)
- Change in serum level of tachykinin 1(The first 48 hours after surgery.)
- Change in serum level of substance P(The first 48 hours after surgery.)
- Change in serum level of dopamine(The first 48 hours after surgery.)