Prevention of Postoperative Delirium With Donepezil

NCT ID: NCT00220896

Last Updated: 2011-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-03-31

Brief Summary

Patients undergoing hip or knee joint replacement at the age of 70 years or above who are cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days), during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3 days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium can be lowered from 20 per cent to 10 per cent by the intervention.

Conditions

Cognitively Normal Elderly Individuals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Donepezil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Cognitively healthy, elective hip or knee replacement

Exclusion Criteria

• Ongoing cholinergic treatment, dementia, delirium, acute physical illness

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Deutschland

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Principal Investigators

Janine Diehl, M. D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Psychiatry, Technische Universitaet Muenchen

Locations

Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich

Munich, , Germany

Countries

Germany

Other Identifiers

PSYTUM1

Identifier Type: -

Identifier Source: org_study_id