Comparison of amisulpride with dexamethasone and ondansetron with dexamethasone for prevention of postoperative nausea and vomiting in adult patients undergoing laparoscopic cholecystectomy: A Randomised Comparative study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- To compare amisulpride with dexamethasone and ondansetron with dexamethasone in the prevention of postoperative nausea and vomiting and in adult patients undergoing laparoscopic cholecystectomy using PONV score
研究概览
简要总结
This is a randomised Comparative study to compare the effect of Amisulpride with dexamethasone and Ondansetron with dexamethasone for prevention of Postoperative Nausea and Vomiting in adult patients undergoing Laparoscopic cholecystectomy to be conducted in ABVIMS and Dr.RML Hospital,New Delhi -110001.
Sample size-208 (104 in each group)
The primary objective is to compare the effectiveness of Amisulpride with dexamethasone and Ondansetron with dexamethasone in preventing PONV in first 24 hrs following surgery.
The secondary objectives are to assess the requirement of rescue anti-emetic, to assess the patient satisfaction and 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
- All
入选标准
- •Patients undergoing Laparoscopic Cholecystectomy.
排除标准
- •Surgery lasting longer than 4 hours.
- •Patients receiving chemotherapy or radiotherapy within the past four weeks.
- •Use of any drugs with emetic or antiemetic action within 24 hours prior to surgery.
- •Pregnant females.
结局指标
主要结局
To compare amisulpride with dexamethasone and ondansetron with dexamethasone in the prevention of postoperative nausea and vomiting and in adult patients undergoing laparoscopic cholecystectomy using PONV score
时间窗: From the end of surgery to next 24 hours
次要结局
- 1. Timing and total requirement of rescue antiemetic.(2. Satisfaction of patient)
研究者
GAGAN S
Atal Bhiari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital