Prevention of Postoperative Delirium With Donepezil

This study has been completed.
Eisai GmbH, Frankfurt, Germany
Information provided by:
Technische Universität München Identifier:
First received: September 14, 2005
Last updated: September 13, 2011
Last verified: September 2011
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:

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

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

Inclusion Criteria:

  • Cognitively healthy, elective hip or knee replacement

Exclusion Criteria:

  • Ongoing cholinergic treatment, dementia, delirium, acute physical illness
  Contacts and Locations
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Please refer to this study by its identifier: NCT00220896

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

No publications provided 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:

Additional relevant MeSH terms:
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 30, 2015