NCT00226785终止3 期
A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol/Midazolam for Continuous Sedation (24 Hours to 14 Days) of Ventilated Patients in Intensive Care Unit
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range
研究概览
简要总结
The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical need for sedation and mechanical ventilation
- •Receiving full intensive care life support
- •Expected stay in ICU of at least 48 hours (h) from time of admission
- •Expected requirement for sedation of at least 24h from time of randomisation
- •Written informed consent within 36h of ICU admission
排除标准
- •Acute severe neurological disorder
- •Acute uncompensated circulatory failure at time of randomisation
- •Severe bradycardia
- •Atrioventricular (AV) conduction block (II-III) unless pacemaker fitted
- •Severe hepatic impairment
- •Need for muscle relaxation at time of randomisation
- •Loss of hearing or vision or any condition interfering significantly with RASS assessment
- •Positive pregnancy test or currently lactating
结局指标
主要结局
Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range
Time from ICU admission to discharge
次要结局
- Frequency of delirium
- Frequency of organ failures and failure-free days
- Nurse's assessment of subject communication
- Duration of mechanical ventilation, weaning time and ventilator-free days in ICU
- Length of total hospital stay
- Functional recovery during hospitalisation
- Need for rescue medication to maintain sedation
- Frequency of critical illness polyneuropathy
- ICU- and in-hospital survival
- Cost of care in the ICU
- Total cost of hospitalisation
- Blood levels of dexmedetomidine seen with long-term treatment
研究者
研究点 (4)
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