CTRI/2024/03/064843尚未招募2 期
Efficacy of amisulpride versus dexamethasone for post operative nausea and vomiting prophylaxis in patients undergoing laparoscopic cholecystectomy- a randomized controlled trial.
Dr Amit Pradhan1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the proportion of Complete Response(defined as no episodes of nausea, retching or vomiting) upto first 24 hours after surgery
研究概览
简要总结
Dexamethasone has been widely used to prevent nausea and vomiting. Amisulpride is recently shown to be effective in preventing vomiting. So we want to compare the efficacy of amisulpride versus dexamethasone in preventing post operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
PRIMARY OBJECTIVE : To compare the efficacy of Amisulpride versus Dexamethasone in prevention of post operative nausea and vomiting
SECONDARY OBJECTIVES:To compare the adverse effects in both the study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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 1& 2 Patients posted for elective Laparoscopic cholecystectomy under endotracheal general anaesthesia.
排除标准
- •1.Any hypersensitivity to the study drugs 2.Administration of antiemetic/steroid 24 hrs prior to anaesthesia 3.Administration of Emetogenic anticancer chemotherapy in previous 4 weeks 4.Pregnant/lactating females 5.Patients on treatment with levodopa/ carbidopa 6.Cardiac arryhthmia, QT interval abnormality 7.Hypokalemia,hypomagnesemia 8.Pre-existing vestibular disease 9.Need of naso/oro-gastric tube after surgery 10.Requirement of post operative mechanical ventilation.
结局指标
主要结局
To compare the proportion of Complete Response(defined as no episodes of nausea, retching or vomiting) upto first 24 hours after surgery
时间窗: 24hours
次要结局
- 1 Incidence and severity of significant nausea(2 Incidence of retching or vomiting)
研究者
Dr Amit Pradhan
Kalinga Institute of Medical Sciences
研究点 (1)
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