EUCTR2008-007384-17-SE进行中（未招募）不适用
A prospective, multi-centre, randomised, double-blind, placebo-controlled comparison of intravenous dexmedetomidine with haloperidol in treatment of hyperactive delirium after heart surgery. - Dex-in-delir
Sten Walther0 个研究点目标入组 75 人开始时间: 2009年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age more than or equal to 65 years
- •- Clinical need for treatment of confusion/agitation unresponsive to standard analgesic medication (RASS +2 to +3, RASS = Richmond Agitation-Sedation Scale)
- •- Heart surgery and extracorporeal circulation (ECC) within 7 days
- •- Written informed consent obtained before surgery
- •- Mentally competent at the time of written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Ongoing neuroleptic, propofol and alpha-2 agonist medication
- •- Intubated patient
- •- Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure [MAP] < 55 mmHg despite volume, pressors and IABP)
- •- Severe bradycardia without pacemaker backup (heart rate [HR] < 50 beats/min)
- •- AV-conduction block II-III (without pacemaker backup)
- •- Severe hepatic impairment (bilirubin > 101 µmol/l)
- •- Lithium therapy
研究者
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