Post Operative Nausea and Vomiting, Sleeve Gastrectomy, Morbid Obesity
Conditions
Keywords
Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, ondansetron, gabapentine
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,
Interventions
DRUGOndansetron 8mg
50 patients will receive intravenous ondansetron 8 mg before the end of surgery.
DRUGGabapentin
50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome of this study will be the complete response within the first 48 h after surgery. | 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
| Measure | Time frame | Description |
|---|---|---|
| change in the level of the biological parameter vasopressin | The first 48 hours after surgery. | 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 | The first 48 hours after surgery. | 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 | The first 48 hours after surgery. | 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 | The first 48 hours after surgery. | 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 | The first 48 hours after surgery. | 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 |
Countries
Egypt
Outcome results
None listed