EUCTR2006-006031-50-EE进行中（未招募）不适用
A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT - Midex
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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 =18 years
- •Clinical need for sedation of an initially intubated (or tracheotomised) and ventilated (with inspiratory assistance) patient
- •Prescribed light to moderate sedation (target RASS = 0 to -3) using midazolam infusion
- •Patients should be randomised = 72 hours from ICU admission and = 48 hours of commencing continuous sedation in the ICU
- •Patients should have an expected requirement for sedation = 24 hours from time of randomisation
- •Written informed consent must be obtained according to local regulations before starting any study procedures other than pre-screening
- •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
- •Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury
- •Uncompensated acute circulatory failure at time of randomisation (severe hypotension with MAP less than 55 mmHg despite volume and pressors)
- •Severe bradycardia (HR less than 50 beats/min)
- •AV-conduction block II-III (unless pacemaker installed)
- •Severe hepatic impairment (bilirubin more than 101 µmol/L)
- •Need for muscle relaxation at the time of randomisation (may only be used for intubation and initial stabilization)
- •Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data
- •Burn injuries and other injuries requiring regular anaesthesia or surgery
- •Use of centrally acting a2 agonists or antagonists (e.g. clonidine, titzanidine, apraclonidine and brimonidine) within 24 hours prior to randomisation
- •Known allergy to any of the study drugs or any excipients of the study drugs
- •Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
- •Patients receiving sedation for therapeutic indications rather than to tolerate the
- •ventilator (e.g. epilepsy)
- •Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barre syndrome)
- •Patients who are 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 advanced amyotrophic lateral sclerosis)
- •Distal paraplegia
- •Positive pregnancy test or currently lactating
- •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, would make it detrimental for the subject to participate in the study
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