NCT01140529终止3 期
A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery
Thorax-Kärlkliniken1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Need for rescue medication
研究概览
简要总结
Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery.
Study design:
Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years
- •Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3)
- •Heart surgery and extracorporeal circulation (ECC) within 7 days
- •Written informed consent obtained before surgery
- •Mentally competent at the time of written informed consent
排除标准
- •Ongoing neuroleptic, propofol and α2 agonist medication
- •Intubated patient
- •Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite volume, vasopressors and IABP)
- •Severe bradycardia without pacemaker backup (heart rate < 50 beats/min)
- •AV-conduction block II-III (without pacemaker backup)
- •Severe hepatic impairment (Serum bilirubin > 101 µmol/l)
- •Lithium therapy
研究组 & 干预措施
Haloperidol
Active Comparator
干预措施: Haloperidol (Drug)
Dexmedetomidine
Experimental
干预措施: Dexmedetomidine (Drug)
Placebo
Placebo Comparator
干预措施: Saline (Drug)
结局指标
主要结局
Need for rescue medication
时间窗: 72 hours
次要结局
未报告次要终点
研究者
Sten Walther
Dr
Thorax-Kärlkliniken
研究点 (1)
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