Comparison of Palonosetron with Ondansetron for prevention of Postoperative Nausea and Vomiting in Female patients undergoing Laparoscopic Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- To measure the incidence of postoperative nausea and vomiting with the use of Palonosetron and Ondansetron in first 24 hrs following Laparoscopic surgeries in female patients using PONV scoring system
研究概览
简要总结
Postoperative nausea and vomiting (PONV) remain common after laparoscopic surgery, especially among female patients. Palonosetron, a second-generation 5-HT3 antagonist with a long half-life, may provide better PONV prophylaxis compared to ondansetron. This prospective randomized interventional study will compare palonosetron (1 mcg/kg IV) and ondansetron (0.1 mg/kg IV) administered before induction of anesthesia in 156 female patients undergoing laparoscopic surgery. Primary outcome is incidence of PONV in 0–24 hours postoperatively. Secondary outcomes include rescue antiemetic requirement, patient satisfaction, adverse effects, and hemodynamic changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients undergoing Laparoscopic Abdominal surgeries of ASA I and II.
排除标准
- •BMI more than or equal to 30kg / m2
- •Patients with a known history of Gastric Esophageal Reflux Disease 3.Allergic to Study drugs.
结局指标
主要结局
To measure the incidence of postoperative nausea and vomiting with the use of Palonosetron and Ondansetron in first 24 hrs following Laparoscopic surgeries in female patients using PONV scoring system
时间窗: 0 hrs, 2 hrs, 6 hrs , 12 hrs, 24 hrs
次要结局
- 1. To assess the need for rescue antiemetics(2. To evaluate Patient Satisfaction score regarding PONV management in both groups)
研究者
Madhumitha V V
Vardhman Mahavir medical college and Safdarjung hospital