Impact of Preoperative Midazolam on Outcome of Elderly Patients: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 782
- 试验地点
- 9
- 主要终点
- Global patient satisfaction on the first postoperative day
研究概览
简要总结
We aim to assess, if placebo compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction
详细描述
Generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. Particularly, in elderly patients (≥65 years), a higher risk for adverse events is described.
Patients will be randomly assigned to one of the following two study groups. Preoperatively, group 1 will receive midazolam and group 2 will receive placebo.
Anaesthesia will be performed according to the clinical routine.
All possible side effects are described in the SmPC for midazolam. For the placebo-group, we do not expect any harm, as in the case of strong preoperative anxiety or agitation, additional midazolam application may occur on behalf of the attending anaesthesist at any time.
The sample size was calculated based on detecting a minimum of 5 unit difference in the primary outcome variable overall patient satisfaction measured with the EVAN-G. Setting a type 1 error of 0.05, a power of 0.8 and assuming the standard deviation of EVAN-G to be 14 units, 248 patients per group are needed to detect a 5 unit difference.
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 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only legally competent patients
- •Written informed consent prior to study participation
- •65-80 years
- •Elective surgery
- •Expected surgery duration ≥ 30 minutes
- •Planned general or combined regional and general anaesthesia
- •Planned extubation at the end of surgery
排除标准
- •Age > 80 years
- •Age < 65 years
- •Non-fluency in German language
- •Alcohol and/ or drugs abuse
- •Chronic benzodiazepine treatment
- •Intracranial surgery
- •Local and stand by anaesthesia or solely regional anaesthesia
- •Monitored anaesthesia care
- •Cardiac surgery
- •Ambulatory surgery
- •Repeated surgery
- •Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)
- •Allergy against any component of the Placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) or investigational drug (midazolam, lactose) or the capsules (gelatine, E171 titanium dioxide, E132 indigotine).
- •Expected benzodiazepine requirement after surgery
- •Expected continuous mandatory ventilation after surgery
- •Patients who explicitly request anxiolytic premedication
- •Patients with severe neurological or psychiatric disorders
- •Refusal of study participation by the patient
- •Parallel participation in interventional clinical studies within the last 30 days
研究组 & 干预措施
Midazolam
Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery
干预措施: Midazolam (Drug)
Placebo
Placebo, oral, once, 30-45 minutes before surgery
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Global patient satisfaction on the first postoperative day
时间窗: on the first postoperative day (1 day)
measured with the EVAN-G questionnaire on the first postoperative day
次要结局
- Delirium testing(preoperative, day 1 after surgery (2 days))
- Cognitive testing(preoperative, day 1 and day 30 after surgery (31 days))
- Major adverse events(30 days)
- Hospital length of stay(on postoperative day 30 (1 day))
- Anaesthesia related data(surgery day (1 day))
- Surgery related data(surgery day (1 day))
- Patients vital data(surgery day (1 day))
- Preoperative anxiety(preoperatively (1 day))
- Change of health-related quality of life(preoperative and day 30 after surgery (31 days))
- Patient cooperation(surgery day (1 day))
- Activities of daily living(preoperative and day 30 after surgery (31 days))
- Number of participants with adverse events and serious adverse events(surgery and first postoperative day (2 days))
- Rescue benzodiazepine application(surgery day (1 day))
- Intensive care unit length of stay(on postoperative day 30 (1 day))
- Perception of pain, well-being, and sleeping(preoperative until first postoperative day (3 days))
- Mortality(30 days)