NCT01091818Unknown3 期
A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time from end of sedation to extubation
研究概览
简要总结
Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.
The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent from parents
- •age between 2 and 18 years
- •anticipated need of respirator treatment for more than 24 hrs
- •included in study within 48 hrs of admission to intensive care unit (ICU)
排除标准
- •severe, unstable circulatory failure
- •severe intracranial or spinal trauma with circulatory instability
- •sever bradycardia or atrioventricular (A-V) block
- •liver failure
- •less than 50% chance of anticipated survival
- •known allergy to study drugs
研究组 & 干预措施
midazolam
Active Comparator
干预措施: Midazolam (Drug)
dexmedetomidin
Experimental
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Time from end of sedation to extubation
时间窗: 1-24 hrs
次要结局
未报告次要终点
研究者
研究点 (1)
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