Antiemetic efficacy of prophylactic amisulpride 5 mg versus amisulpride 10 mg in patients undergoing cardiac surgery under cardiopulmonary bypass machine: A randomized double-blinded, controlled 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: Comparison of antiemetic efficacy of amisulpride 5 mg with that of amisulpride 10 mg in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing cardiac surgery under cardio-pulmonary bypass machine
Methods: Study will be conducted after Ethics committee approval in adult patients of either sex belonging to ASA PS II and III class undergoing cardiac surgery under cardio-pulmonary bypass machine. Patients (total 140) will be randomly assigned into two groups: Group A: receiving amisulpride 5 mg intravenously; Group B: receiving amisulpride 10 mg intravenously
Objectives:
Primary- Antiemetic efficacy of amisulpride 5 mg versus amisulpride 10 mg
Secondary- 1) requirement of rescue antiemetic (dexamethasone 8 mg)
- effect of amisulpride on QT interval 3) any other adverse event due to amisulpride
Study period : 1 year
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA PS II and III 2) scheduled to undergo elective valvular heart repair under cardiopulmonary bypass machine.
排除标准
- •Known allergy/hypersensitivity to the drug used in the study 2) patients with ventricular arrhythmias 3) patients with preoperative cardiopulmonary resuscitation 4) preoperative mechanical ventilation or dialysis 5) patients who underwent surgical reexploration.
研究者
Dr Sanjeev Kumar
IMS BHU