NCT02845960Unknown不适用
The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- PSQI index
研究概览
简要总结
The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary unilateral total knee artropasty;
- •Patients with Knee osteoartritis or Rheumatoid arthritis;
- •Able and willing to provide signed informed consent.
排除标准
- •Simultaneously bilateral total knee artropasty or revision case;
- •Surgical History of the knee joint;
- •Knee joint cavity paracentesis in recent 3 months;
- •Stiffness with knee;
- •Blood coagulation disorders;
- •History of deep venous thrombosis;
- •Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
- •allergic to NSAIDs, opioid analgesics, zolpidem
- •sleep apnea, Parkinson disease, dementia, depression
- •use of sedatives or hypnotics
- •inability to comply with polysomnographic measurement
结局指标
主要结局
PSQI index
时间窗: 1 mounth
Insomnia severity index
时间窗: 1 mounth
VAS
时间窗: 1 mounth
GAD-7
时间窗: 1 mounth
polysomnographic measurement
时间窗: 1 mounth
WOMAC score
时间窗: 1 mounth
Range of motion
时间窗: 1 mounth
次要结局
未报告次要终点
研究者
Liu Yang
Professor
Southwest Hospital, China
研究点 (1)
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