EUCTR2016-004555-79-DE进行中（未招募）1 期
Impact of preoperative midazolam on outcome of elderly patients: a multicenter randomised controlled trial - I-PROMOTE
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty0 个研究点目标入组 614 人开始时间: 2017年4月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 614
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
入选标准
- •1.Only legally competent patients
- •2.Written informed consent prior to study participation
- •3.65-80 years
- •4.Elective surgery
- •5.Expected surgery duration = 30 minutes
- •6.Planned general or combined regional and general anaesthesia
- •7.Planned extubation at the end of surgery
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 614
排除标准
- •1.Age > 80 years
- •2.Age < 65 years
- •3.Non-fluency in German language
- •4.Alcohol and/ or drugs abuse
- •5.Chronic benzodiazepine treatment
- •6.Intracranial surgery
- •7.Local and stand by anaesthesia or solely regional anaesthesia
- •8.Monitored anaesthesia care
- •9.Cardiac surgery
- •10.Ambulatory surgery
- •11.Repeated surgery
- •12.Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)
- •13. Allergy against any component of the Placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) orinvestigational drug (midazolam, lactose) or the capsules (gelatine, E171 titanium dioxide, E132 indigotine)
- •14.Expected benzodiazepine requirement after surgery
- •15.Expected continuous mandatory ventilation after surgery
- •16.Patients who explicitly request anxiolytic premedication
- •17.Patients with severe neurological or psychiatric disorders
- •18.Refusal of study participation by the patient
- •19.Parallel participation in interventional clinical studies within the last 30 days
研究者
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