Prevention of Postoperative Delirium With Donepezil - Full Text View

Prevention of Postoperative Delirium With Donepezil

This study is not yet open for participant recruitment.
Verified by Technische Universität München, September 2005

Sponsors and Collaborators:	Technische Universität München 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

ChemIDplus related topics:

Donepezil E 2020

U.S. FDA Resources

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

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	Not yet recruiting
	Munich, Germany, D-81675
	Contact: Alexander Kurz, M. D. +49-89-4140-4285 alexander.kurz@lrz.tum.de
	Principal Investigator: Janine Diehl, M. D.

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

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

Keywords provided by Technische Universität München:

Delirium

Prevention

Donepezil

Study placed in the following topic categories:

Donepezil

Delirium

Additional relevant MeSH terms:

Nootropic Agents

Cholinesterase Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Enzyme Inhibitors

Cholinergic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008