NCT01993459已完成4 期
A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change in Quality of Recovery (QoR-40 Scale)
研究概览
简要总结
The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patiënts operated with a laparotomy in the Erasmus Medical Center of Rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days
排除标准
- •Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients
研究组 & 干预措施
Midazolam intravenous
Experimental
3mg/ml midazolam given intravenously
干预措施: Midazolam (Drug)
NaCl (sodium chloride) 0,9%
Placebo Comparator
NaCl (sodium chloride) 0,9% given intravenously 3ml.
干预措施: NaCl (sodium chloride) 0,9% (Drug)
结局指标
主要结局
Change in Quality of Recovery (QoR-40 Scale)
时间窗: baseline, workday 3 postoperative, workday 7 postoperative
次要结局
- Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).(baseline, workday 7 postoperative)
- Change in Systolic bloodpressure(baseline, workday 1 postoperative)
- Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)(baseline, workday 7 postoperative)
- Temperature after surgery measured with an ear thermometer(directly after surgery)
- Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)(baseline, workday 1 postoperative, workday 7 postoperative)
- Change in Diastolic Blood pressure(baseline, workday 1 postoperative)
- Change in Heart Rate(preoperatively, during surgery and postoperatively)
- Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)(baseline, workday 1 postoperative, workday 7 postoperative)
- Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)(baseline, workday 7 postoperative)
研究者
Stefan van Beek
BSc
Erasmus Medical Center
研究点 (1)
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