Comparison of Amisulpride and Ondansetron for the prevention of Postoperative Nausea and Vomiting in patients undergoing laparoscopic gynaecological surgeries
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting in the first 24 hours following surgery measured using postoperative Nausea score, Postoperative vomiting score and PONV score
研究概览
简要总结
This is a randomised Comparative study to compare the effect of Amisulpride and Ondansetron for prevention of Postoperative Nausea and Vomiting in adult patients undergoing Laparoscopic Gynaecological surgery to be conducted in ABVIMS and Dr.RML Hospital,New Delhi -110001.
Sample size-200 (100 in each group)
The primary objective is to compare the effectiveness of Amisulpride and Ondansetron in preventing PONV in first 24 hrs following surgery.
The secondary objectives are to assess the requirement of rescue anti-emetic and to assess the incidence of adverse effects in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females undergoing Laparoscopic Gynaecological surgery.
排除标准
- •Patients having history of motion sickness or past history of PONV.
- •History of allergy to the drug to be given.
- •Patients with liver disease.
- •Patients receiving chemotherapy or radiotherapy within the past four weeks.
结局指标
主要结局
Incidence of postoperative nausea and vomiting in the first 24 hours following surgery measured using postoperative Nausea score, Postoperative vomiting score and PONV score
时间窗: From end of surgery to 24 hrs after end of surgery
次要结局
- 1) Requirement of rescue anti-emetic in both groups.(2) Incidence of adverse effects like headache, dizziness, dizziness etc)
研究者
Dr Rupesh Yadav
ABVIMS and Dr.RML Hospital