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Prevention of Postoperative Delirium With Donepezil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00220896
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 14, 2011
Sponsor:
Collaborator:
Eisai Deutschland
Information provided by:
Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Cognitively Normal Elderly Individuals Drug: Donepezil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : January 2006
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Incidence of delirium

Secondary Outcome Measures :
  1. Cognitive performance


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cognitively healthy, elective hip or knee replacement

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220896


Locations
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Germany
Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich
Munich, Germany, D-81675
Sponsors and Collaborators
Technische Universität München
Eisai Deutschland
Investigators
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Principal Investigator: Janine Diehl, M. D. Dept. of Psychiatry, Technische Universitaet Muenchen

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ClinicalTrials.gov Identifier: NCT00220896    
Other Study ID Numbers: PSYTUM1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011
Keywords provided by Technische Universität München:
Delirium
Prevention
Donepezil
Additional relevant MeSH terms:
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Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents