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

Completed

• Conditions: Post-operative delirium; Surgery; Post-operative problems

• Registration Number: ISRCTN55655483
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Awaiting elective total hip or knee replacement
2. 65 years old or over
3. Valid written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study will be the incidence of post-operative delirium. Patients will be considered as a case of delirium if at any point during the course of follow up (to Day seven) they develop an episode of delirium. A risk ratio will be calculated.<br><br>Delirium will be diagnosed using the Confusion Assessment Method (CAM) as the primary outcome variable. This is the most widely used instrument for the detection of delirium in the acute hospital setting. It has a sensitivity of 94-100% and a specificity of 90-95% and generates a Diagnostic and Statistical Manual of mental disorders - Fourth Edition (DSM IV) diagnosis of delirium.