Laparoscopic Sleeve Gastrectomy, Morbid Obesity, Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, baclofen, Morbid Obesity
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
Interventions
DRUGBaclofen Tablets
10 mg oral baclofen 1 h before anesthesia
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome of this study will be the complete response | 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 serum level of vasopressin | The first 48 hours after surgery. | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery |
| Change in serum level of substance P | The first 48 hours after surgery. | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery |
| Change in serum level of dopamine | The first 48 hours after surgery. | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery |
| Change in serum level of serotonin | The first 48 hours after surgery. | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery |
| Change in serum level of tachykinin 1 | The first 48 hours after surgery. | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery |
Countries
Egypt
Outcome results
None listed