Prevention of Postoperative Delirium With Donepezil

This study is not yet open for participant recruitment.

Verified by Technische Universität München, September 2005

First Received: September 14, 2005 No Changes Posted

Sponsor:	Technische Universität München
Collaborator:	Eisai GmbH, Frankfurt, Germany
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00220896

Purpose

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.

Condition	Intervention	Phase
Cognitively Normal Elderly Individuals	Drug: Donepezil	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

Incidence of delirium

Secondary Outcome Measures:

Cognitive performance

Estimated Enrollment:	300
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cognitively healthy, elective hip or knee replacement

Exclusion Criteria:

Ongoing cholinergic treatment, dementia, delirium, acute physical illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220896

Contacts

Contact: Janine Diehl, M. D.

+49-89-4140-4279

janine.diehl@lrz.tum.de

Locations

Germany
Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich
Munich, Germany, D-81675

Sponsors and Collaborators

Technische Universität München

Eisai GmbH, Frankfurt, Germany

Investigators

Principal Investigator:

Janine Diehl, M. D.

Dept. of Psychiatry, Technische Universitaet Muenchen

More Information

No publications provided

Study ID Numbers:	PSYTUM1
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00220896 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:

Delirium
Prevention
Donepezil

Additional relevant MeSH terms:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Donepezil
Enzyme Inhibitors
Cholinergic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009