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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620641
Other study ID # 35647
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 1, 2022
Est. completion date August 2024

Study information

Verified date November 2023
Source Tanta University
Contact Aya Moussa, assistant lecturer
Phone 01222607803
Email aya.mosa@pharm.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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,


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: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ondansetron 8mg
50 patients will receive intravenous ondansetron 8 mg before the end of surgery.
Gabapentin
50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

Locations

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

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 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 The first 48 hours after surgery.
Secondary 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 The first 48 hours after surgery.
Secondary 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 The first 48 hours after surgery.
Secondary 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 The first 48 hours after surgery.
Secondary 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 The first 48 hours after surgery.
Secondary 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 The first 48 hours after surgery.
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