NCT00286936终止4 期
Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Incidence and severity of postoperative delirium
研究概览
简要总结
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery
详细描述
Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components
排除标准
- •Severe respiratory insufficiency
结局指标
主要结局
Incidence and severity of postoperative delirium
次要结局
- mobilization
- Sleep quality
- loss of functional ability
- length of stay
- sedation
- nocturnal nursing events
研究者
研究点 (2)
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