Clinical trial NCT05620641: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Nausea and Vomiting
Sleeve Gastrectomy
Morbid Obesity
Keywords: Postoperative Nausea and Vomiting
Laparoscopic Sleeve Gastrectomy
ondansetron
gabapentine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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,

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.

Primary outcomes:
measure: The primary outcome of this study will be the complete response within the first 48 h after surgery.
timeFrame: The first 48 hours after surgery.
Secondary outcomes:
measure: change in the level of the biological parameter vasopressin
timeFrame: The first 48 hours after surgery.
measure: change in the level of the biological parameter dopamine
timeFrame: The first 48 hours after surgery.
measure: change in the level of the biological parameter substance p
timeFrame: The first 48 hours after surgery.
measure: change in the level of the biological parameter Serotonin
timeFrame: The first 48 hours after surgery.
measure: change in the level of the biological parameter Tachykinin 1
timeFrame: The first 48 hours after surgery.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt
state: Gharbiya
Study officials:
References: