EUCTR2011-001490-40-IT进行中（未招募）不适用
Comparative evaluation of the effects of dexmedetomidine and propofol on patient/ventilator interaction in difficult-to-wean mechanically ventilated patients; a prospective, open, randomised, multicentre study. - DoVeS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Written informed consent obtained from the patient. •18 years or older. •Patients who have failed one weaning trial. •Receiving propofol as a sole agent for continuous sedation (minimum 12 hours) with target sedation level Richmond Agitation-Sedation Scale (RASS) +1 to -2 (must be in target at randomisation). •Intubated and mechanically ventilated in the ICU for more than 24 hours. •Patient has nasogastric (NG)/feeding tube in-situ.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Patients who have failed more than one weaning trial. •Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury. •Uncompensated acute circulatory failure at the time of randomisation (severe hypotension with mean arterial pressure less than 55 mmHg despite volume and vasopressors). •Severe bradycardia (heart rate [HR] less than 50 bpm). •AV conduction block II-III (unless pacemaker installed). •Unstable angina or acute myocardial infarction. •Severe hepatic impairment (bilirubin more than 101 ?mol/l). •Need for muscle relaxation at the time of randomisation (could only be used for intubation and initial stabilisation). •Acute renal failure requiring dialytic treatment of all types. •Pregnancy or breastfeeding. •Patients with tracheostomy. •Use of centrally acting alpha-2 agonists or antagonists (e.g. clonidine, titzanidine, apraclonidine and brimonidine) within 24 hours prior to randomisation. •Patients expected to have treatment withdrawn or withheld due to poor prognosis. •Patients unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or amyotrophic lateral sclerosis). •Received any investigational drug within the preceding 30 days. •Concurrent participation in any other interventional study (any study in which patients are allocated to different treatment groups and/or non-routine diagnostic or monitoring procedures are performed). •Previous participation in this study. •Any other condition which, in the investigator’s opinion, could make it detrimental for the patient to participate in the study.
研究者
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