Antiemetic efficacy of prophylactic amisulpride versus palonosetron in patients undergoing Total Laparoscopic Hysterectomy: A randomized, double-blinded trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
Aim: To compare the antiemetic efficacy of amisulpride with that of palonosetron for prevention of postoperative nausea and vomiting in patients undergoing total laparoscopic hysterectomy.
Methods: Study will be conducted after ethics committee approval in female patients of ASA PS I and II undergoing total laparoscopic hysterectomy. Patients (total 140) will be randomly assigned into two groups:
Group A: amisulpride 10 mg i.v. after induction of general anaesthesia
Group P: receiving palonosetron 0.075 mg i.v. after induction of general anaesthesia
PONV will be assessed at specified time intervals in the postoperative period upto 48 hours after surgery. Need of rescue antiemetic requirement and the effect of duration of surgery on PONV will also be noted.
Primary objective: Prevention of PONV in postoperative period
Secondary objective: 1) Need of rescue antiemetic.
- Effect of duration of surgery on PONV
Study period: 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged between 40-60 years 2) ASA PS I and II 3) Patients scheduled for total laparoscopic hysterectomy.
排除标准
- •Patients having history of CAD, COPD, DM 2) Patients in which laparoscopic surgery gets converted to open surgery 3) Patients requiring postoperative ventilation.
研究者
Dr Anand Soliya
IMS BHU