EUCTR2007-000262-20-GB进行中（未招募）1 期
A phase III, 7 days randomised, double-blind, placebo-controlled, parallel group study to assess efficacy of DPZ for reducing the symptoms of post-operative delirium after an elective hip or knee replacement in patients over 65 years old. - DPZ and post-operative delirium
Stanmore Clinical Research Facility Ltd0 个研究点目标入组 300 人开始时间: 2007年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •Inclusion Criteria:
- •Awaiting elective total hip or knee replacement
- •65 years old or over
- •Valid written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with delirium as defined by the CAM
- •Subjects undergoing revision/complex hip/knee surgery
- •Subjects who are deaf, visually impaired or have insufficient English to the extent where they cannot complete the study assessments.
- •Subjects with moderately severe cognitive impairment at baseline (i.e. MMSE <20)
- •Subjects with alcohol dependence syndrome (ICD-10 definition)
- •Subjects with severe nausea and vomiting precluding the use of DPZ
- •Subjects currently taking cholinesterase inhibitors
- •Subjects taking antipsychotic/ neuroleptic medication that may mask symptoms of delirium
- •Hypnotics or anxiolytics initiated less than a month ago
- •Subjects with a known hypersensitivity to DPZ (piperidine derivatives or any excipients used in its formulation – or that of the placebo)
- •Severe bladder outflow obstruction
- •Spinal anaesthesia during surgery
- •Subjects with cardiac problems that contraindicate the prescription of cholinesterase inhibitors:
- •oSick sinus syndrome
- •oResting pulse of <50
- •oSupraventricular conduction defects
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