EUCTR2006-001276-20-DE进行中（未招募）不适用
A randomized, open-label, multicenter, parallel-group study to compare the efficacy, safety and resource utilization of a remifentanil/propofol analgosedation regimen versus a sufentanyl/propofol analgosedation regimen in ventilated patients under intensive medical care with an expected duration of analgosedation of up to 7 days
适应症
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
- 164
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
- •A patient must not be included in this clinical trial unless all of the following inclusion criteria are fulfilled:
- •1. Written informed consent was obtained from the patient
- •2. The patient is under intensive medical care, intubated and ventilated
- •3. The expected duration of ventilation and analgosedation is > 24 hours and = 7 days
- •4. Propofol is intended to be used as sedativum
- •5. Age = 18 years
- •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
- •A patient must not be included in this clinical trial if any of the exclusion criteria are fulfilled:
- •1. Contraindication against administration of remifentanil, sufentanyl, or propofol
- •2. Concomitant medications:
- •The patient is receiving epidural analgesia or a peripheral regional analgesic therapy.
- •The patient is requiring muscle relaxants to facilitate mechanical ventilation
- •3. The patient participated in clinical drug trials within the previous 30 days or par-ticipated in this clinical trial before or is currently participating in any other clinical trial
- •4. The patient has a known hypersensitivity to the drugs under investigation or to propofol
- •5. For female patients: the patient is pregnant or breastfeeding
- •6. The patient is classified as ASA V or moribund
- •7. The patient must be expected to show an impaired cerebral or neurologic capacity due to illness, trauma or other interventions, which will interfere with the collection of the analgosedation scores and the waking behavior as for example, without be-ing limited to:
- •Hypoxic brain damage
- •Cerebrocanial trauma grades II, III, and IV
- •Subarachnoid hemorrhage, brain-stem hemorrhage, ischemic-hemorrhagic cerebral hemorrhages
- •Amyotrophic lateral sclerosis, myasthenia gravis
- •Stupor or coma
- •8. The patient requires chronic ventilation
- •9. The patient is receiving chronic (> 3 months) therapy with high-potency opioids / WHO level 3
- •10. The patient is alcohol or drug dependent (legal or illegal drugs in particular, but not exclusively with dependency on sedatives or benzodiazepines), defined as:
- •Typically an urgent desire to take the substance, problems in controlling con-sumption, and persistent use of the substance despite adverse consequences. The use of the substance has priority over other activities and responsibilities. Developing increased tolerance and occasionally physical withdrawal symp-tom.
- •11. The patient suffers from an apparent organ failure
- •12. Patients with severe cardiac insufficiency or severe cardiac arrhythmia
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