ISRCTN55655483已完成不适用
A phase III, seven-day randomised, double-blind, placebo-controlled, parallel group study to assess efficacy of Donepezil for reducing the incidence and severity of Post-Operative Delirium after an elective total hip or knee replacement in patients over 65 years old
Imperial College London (UK)0 个研究点目标入组 300 人开始时间: 2007年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Awaiting elective total hip or knee replacement
- •2. 65 years old or over
- •3. Valid written informed consent
排除标准
- •1. Subjects with delirium as defined by the Confusion Assessment Method (CAM)
- •2. Subjects undergoing revision/complex hip/knee surgery
- •3. Subjects who are deaf, visually impaired or have insufficient English to the extent where they cannot complete the study assessments
- •4. Subjects with moderately severe cognitive impairment at baseline (i.e. Mini Mental State Examination [MMSE] less than 20)
- •5. Subjects with alcohol dependence syndrome (International Classification of Diseases [ICD-10] definition)
- •6. Subjects with severe nausea and vomiting precluding the use of DPZ
- •7. Subjects currently taking cholinesterase inhibitors
- •8. Subjects taking antipsychotic/neuroleptic medication that may mask symptoms of delirium
- •9. Hypnotics or anxiolytics initiated less than a month ago
- •10. Subjects with a known hypersensitivity to DPZ (piperidine derivatives or any excipients used in its formulation ? or that of the placebo)
- •11. Severe bladder outflow obstruction
- •12. Spinal anaesthesia during surgery
- •13. Subjects with cardiac problems that contraindicate the prescription of cholinesterase inhibitors:
- •13.1. Sick sinus syndrome
- •13.2. Resting pulse of less than 50
- •13.3. Supraventricular conduction defects
研究者
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