NCT01551485Unknown不适用
Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in sleep time on the first postoperative night compared to preoperatively.
研究概览
简要总结
Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total hip or knee replacement in fast-track setup
- •Age 60 years or above
- •ASA class 1-3
排除标准
- •Anesthesia within the pas 30 days
- •Daily use of alcohol > 21 units / week
- •Use of anxiolytics or hypnotics within the past 30 days
- •Inability to read and understand Danish
- •Marked reduction of sight or hearing
- •Parkinson's disease or other neurological disaese causing function deficits
- •Inability to cooperate to sleep monitoring
- •allergy to the drug tested
研究组 & 干预措施
Zolpidem
Experimental
干预措施: Zolpidem (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in sleep time on the first postoperative night compared to preoperatively.
时间窗: first night postoperatively - 24 hours
The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual
次要结局
未报告次要终点
研究者
Lene Krenk
Principal investigator
Rigshospitalet, Denmark
研究点 (1)
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