Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome of this study will be the complete response within the first 48 h after surgery.
研究概览
简要总结
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.
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- Patients with BMI >55 kg/m
- •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.
研究组 & 干预措施
Group 1
include 50 patients scheduled for sleeve gastrectomy
干预措施: Ondansetron 8mg (Drug)
Group 2
include 50 patients scheduled for sleeve gastrectomy
干预措施: Gabapentin (Drug)
结局指标
主要结局
The primary outcome of this study will be the complete response within the first 48 h after surgery.
时间窗: 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
次要结局
- change in the level of the biological parameter dopamine(The first 48 hours after surgery.)
- change in the level of the biological parameter substance p(The first 48 hours after surgery.)
- change in the level of the biological parameter Serotonin(The first 48 hours after surgery.)
- change in the level of the biological parameter vasopressin(The first 48 hours after surgery.)
- change in the level of the biological parameter Tachykinin 1(The first 48 hours after surgery.)
研究者
Aya Gamal Moussa
Assistant Lecturer at Clinical Pharmacy department , Faculty of Pharmacy -Tanta University
Tanta University