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Prevention of Postoperative Delirium With Donepezil

This study has been completed.
Sponsor:
Collaborator:
Eisai GmbH, Frankfurt, Germany
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00220896
First received: September 14, 2005
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Incidence of delirium

Secondary Outcome Measures:
  • Cognitive performance

Enrollment: 37
Study Start Date: January 2006
Study Completion Date: March 2009
  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

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

ClinicalTrials.gov Identifier: NCT00220896     History of Changes
Other Study ID Numbers: PSYTUM1
Study First Received: September 14, 2005
Last Updated: September 13, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Delirium
Prevention
Donepezil

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
 Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013