Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery
研究概览
简要总结
Laparoscopic sleeve gastrectomy (LSG) is an emerging treatment modality among the various types of surgical approach to obesity (1). The incidence of PONV in obese patients undergoing bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 % (2,3). Postoperatively, bariatric patients appear to suffer from nausea and vomiting more frequently than normal weight or obese patients.
详细描述
Currently, available interventions for PONV prophylaxis, especially as monotherapy, lack universal efficacy. Use of combination therapies with different pharmacological basis is likely to bring down rates of PONV. (6) Intravenous dexamethasone (8-10mg) reduces the incidence of PONV, minimizing activity of phospholipase A2 and blocking the expression of cyclooxygenase (COX)2 mRNA that reduce production of prostaglandin and control the release of endorphins.
Aprepitant has demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV), and in the prevention of postoperative nausea and vomiting (PONV) The use of mirtazapine in the management of nausea and vomiting has been reported for both treatment and premedication
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, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Body mass index (BMI) ≥ 35 kg/cm-2
排除标准
- •Patients with gastrointestinal disorders,
- •Patients with significant major organ disease,
- •Patients received antidepressant drugs,
- •Patients received an anti-emetic drug within 48 h before surgery,
- •Patients on treatment with systemic glucocorticoids within 4 weeks before surgery.
研究组 & 干预措施
Aprepitant/Dexamethasone Group
干预措施: Aprepitant and Dexamethasone (Drug)
Mertazepine /Dexamethasone Group
干预措施: Mirtazapine and Dexamethasone (Drug)
Dexamethasone Group
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery
时间窗: First 24 hours(h) postoperative.
Incidence (%) of nausea and vomiting in 24 hours(h) postoperative
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University