To compare efficacy of prevention of post operative nausea and vomiting between amisulpride and palonosetron in patients undergoing laparoscopic cholecystectomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- 2. To assess the severity of nausea and vomiting as recorded by PONV score.
研究概览
简要总结
This is a prospective randomized double blind comparative study in ASA I and II patients aged 18 years or older undergoing elective laparoscopic cholecystectomy under general anesthesia. A total of 244 patients will be randomized into two groups by block randomization. Group AMP will receive intravenous amisulpride 10 mg and Group PLS will receive intravenous palonosetron 75 mcg at induction of anesthesia. Standardized anesthetic technique will be followed for all patients. Postoperative data on nausea, vomiting and retching will be collected at 0 to 2 hours in the recovery room and from 2 to 24 hours in the ward. Rescue antiemetics will be given if PONV score is more than one. Adverse effects related to study drugs and patient satisfaction will also be recorded. Patients converted to open surgery will be withdrawn from the study.
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
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of either sex ASA Physical Status I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia.
排除标准
- •Patients will be excluded if they refuse consent OR belong to ASA physical status class III or IV OR are undergoing emergency laparoscopic surgery OR are smokers or alcoholics OR are pregnant or lactating OR have a history of postoperative nausea/vomiting or motion sickness OR are allergic to amisulpride or palonosetron OR have significant liver or renal disease OR are already on antiemetics, steroids, or psychomimetic drugs preoperatively OR if the surgery duration is greter than or equal to 3 hours.
结局指标
主要结局
2. To assess the severity of nausea and vomiting as recorded by PONV score.
时间窗: 10 MONTHS
1. To compare the incidence of nausea, vomiting and retching during post-operative 24 hrs in patients undergoing laparoscopic cholecystectomy.
时间窗: 10 MONTHS
3. The number and timing of doses of rescue antiemetic used during post op 24 hrs
时间窗: 10 MONTHS
次要结局
- To compare:(1. patient satisfaction score and)
研究者
Dr Saloni Das
IMS & SUM Hospital