Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 2 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
研究概览
简要总结
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.
详细描述
. 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
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)
盲法说明
double blind
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
- •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 2
which include 50 patients scheduled for sleeve gastrectomy
干预措施: Baclofen Tablets (Drug)
结局指标
主要结局
The primary outcome of this study will be the complete response
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 serum level of vasopressin(The first 48 hours after surgery.)
- Change in serum level of serotonin(The first 48 hours after surgery.)
- Change in serum level of tachykinin 1(The first 48 hours after surgery.)
- Change in serum level of substance P(The first 48 hours after surgery.)
- Change in serum level of dopamine(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