Back to resultsOndansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
Primary Purpose
Post Operative Nausea and Vomiting, Sleeve Gastrectomy, Morbid Obesity
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ondansetron 8mg
Gabapentin
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, ondansetron, gabapentine
Eligibility Criteria
Inclusion Criteria: Both male and female patients will be included. 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, Tanta, EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
include 50 patients scheduled for sleeve gastrectomy
include 50 patients scheduled for sleeve gastrectomy
Outcomes
Primary Outcome Measures
The primary outcome of this study will be the complete response within the first 48 h after surgery.
Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy
Secondary Outcome Measures
change in the level of the biological parameter vasopressin
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin
change in the level of the biological parameter dopamine
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine
change in the level of the biological parameter substance p
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p
change in the level of the biological parameter Serotonin
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin
change in the level of the biological parameter Tachykinin 1
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05620641
Brief Title
Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
Official Title
Comparative Clinical Study Among Ondansetron and Gabapentin 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
October 1, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
Detailed Description
This study will be a double blind randomized, controlled, parallel, study. A total of1 00 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 two groups by closed envelop method,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Nausea and Vomiting, Sleeve Gastrectomy, Morbid Obesity
Keywords
Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, ondansetron, gabapentine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
include 50 patients scheduled for sleeve gastrectomy
Arm Title
Group 2
Arm Type
Experimental
Arm Description
include 50 patients scheduled for sleeve gastrectomy
Intervention Type
Drug
Intervention Name(s)
Ondansetron 8mg
Other Intervention Name(s)
zofran
Intervention Description
50 patients will receive intravenous ondansetron 8 mg before the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.
Primary Outcome Measure Information:
Title
The primary outcome of this study will be the complete response within the first 48 h after surgery.
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 the level of the biological parameter vasopressin
Description
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin
Time Frame
The first 48 hours after surgery.
Title
change in the level of the biological parameter dopamine
Description
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine
Time Frame
The first 48 hours after surgery.
Title
change in the level of the biological parameter substance p
Description
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p
Time Frame
The first 48 hours after surgery.
Title
change in the level of the biological parameter Serotonin
Description
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin
Time Frame
The first 48 hours after surgery.
Title
change in the level of the biological parameter Tachykinin 1
Description
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1
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:
Both male and female patients will be included.
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, assistant lecturer
Phone
01222607803
Email
aya.mosa@pharm.tanta.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
tarek mostafa, professor
Phone
01154594035
Email
Toulouse1985@yahoo.com
Facility Information:
Facility Name
Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt
City
Tanta
State/Province
Gharbiya
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
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