CTRI/2017/09/009943招募中3 期
Comparison of oral midazolam with two different doses of oral dexmedotimidine for premedication in pediatric patients-A Randomised control double blind study.
Dusu Lalin1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年4月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sedation score after Premedication.
研究概览
简要总结
To compare oral dexmedetomidine to oral midazolam for premedication in paediatric patients. To find most optimum dose of dexmedetomidine for oral premedication. 300 patients to be enrolled for study in age group 1 yrs to 7 yrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and
- •Age 1-7 years.
- •Any surgery under general anesthesia.
排除标准
- •Haemodynamically unstable Mental retardation or neurobehavioral disorders.
- •Treatment with sedatives or anticonvulsants.
结局指标
主要结局
Sedation score after Premedication.
时间窗: 60 minutes after Premedication
次要结局
- Parents seperation anxiety, Mask acceptance on Induction , Anxiety in PACU(1 hour, At induction and In PACU.)
研究者
研究点 (1)
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