Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- the number of participants with delirium
研究概览
简要总结
Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Investigators aimed to establish the preventive effect of the cholinesterase inhibitor, rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation in patients at risk of dementia.
详细描述
Investigators evaluated the delirium prevention effect of rivastigmine patch in patients with femur neck fracture and cognitive impairment. Investigators measured the frequency and severity of post-operation delirium in the patch applied and non-applied subjects.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutively enrolled the patients who is going to operation after femur neck fracture.
- •Patients agree to the informed consent.
排除标准
- •depressive mood and their geriatric depression scale is over 6 /
- •Their Korean version MMSE(minimental status examination) are over 25, or global dementia scale (GDS) are under 3 or over
- •any delirious state at pre-operation period by DSM IV and CAM (Confusion Assessment Method)
研究组 & 干预措施
Patch applied patients
The investigators had enrolled consecutively the patients who were going to operation after femur neck fracture.
Participants were applied the 5 unit rivastigmine patches from 3 days before and 7 days after the femur neck operation.
干预措施: Rivastigmine patch (Drug)
结局指标
主要结局
the number of participants with delirium
时间窗: up to 7th days
investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants.
次要结局
- delirium severity using delirium rating scale(up to 7th days)
研究者
Youn Young Chul
Professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine