Morbid Obesity Clinical Trial
Official title:
Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt | Tanta | Gharbiya |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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Secondary | change in the level of the biological parameter vasopressin | 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture.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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