Back to resultsBaclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery
Primary Purpose
Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, Morbid Obesity
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Baclofen Tablets
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, baclofen, Morbid Obesity
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/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.
Sites / Locations
- Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Group 1(Control group)
Group 2
Arm Description
include 50 patients scheduled for sleeve gastrectomy
which include 50 patients scheduled for sleeve gastrectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in serum level of vasopressin
Blood samples will be collected at baseline, 24 hours and 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
Change in serum level of dopamine
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Change in serum level of serotonin
Blood samples will be collected at baseline, 24 hours and 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05516953
Brief Title
Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery
Official Title
Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, Morbid Obesity
Keywords
Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, baclofen, Morbid Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1(Control group)
Arm Type
No Intervention
Arm Description
include 50 patients scheduled for sleeve gastrectomy
Arm Title
Group 2
Arm Type
Experimental
Arm Description
which include 50 patients scheduled for sleeve gastrectomy
Intervention Type
Drug
Intervention Name(s)
Baclofen Tablets
Other Intervention Name(s)
baclofen
Intervention Description
10 mg oral baclofen 1 h before anesthesia
Primary Outcome Measure Information:
Title
The primary outcome of this study will be the complete response
Description
Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy.
Time Frame
The first 48 hours after surgery.
Secondary Outcome Measure Information:
Title
Change in serum level of vasopressin
Description
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time Frame
The first 48 hours after surgery.
Title
Change in serum level of substance P
Description
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time Frame
The first 48 hours after surgery.
Title
Change in serum level of dopamine
Description
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time Frame
The first 48 hours after surgery.
Title
Change in serum level of serotonin
Description
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time Frame
The first 48 hours after surgery.
Title
Change in serum level of tachykinin 1
Description
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time Frame
The first 48 hours after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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/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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Moussa
Phone
01222607803
Email
aya.mosa@pharm.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya Moussa
Organizational Affiliation
Faculty of pharmacy, Tanta university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital.
City
Tanta
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya Moussa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery
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