Prevention of Postoperative Delirium With Donepezil - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

September 14, 2005

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of delirium

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Cognitive performance

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Prevention of Postoperative Delirium With Donepezil

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cognitively Normal Elderly Individuals

Intervention ^ICMJE

Drug: Donepezil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

300

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cognitively healthy, elective hip or knee replacement

Exclusion Criteria:

Ongoing cholinergic treatment, dementia, delirium, acute physical illness

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Janine Diehl, M. D.

+49-89-4140-4279

janine.diehl@lrz.tum.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00220896

Responsible Party

Study ID Numbers ^ICMJE

PSYTUM1

Study Sponsor ^ICMJE

Technische Universität München

Collaborators ^ICMJE

Eisai GmbH, Frankfurt, Germany

Investigators ^ICMJE

Principal Investigator:

Janine Diehl, M. D.

Dept. of Psychiatry, Technische Universitaet Muenchen

Information Provided By

Technische Universität München

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP