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Clinical Trial: Prevention of Postoperative Delirium with Donepezil
This study is not yet open for patient recruitment.
Verified by Technische Universität München September 2005
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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 |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Incidence of delirium
Secondary Outcomes: Cognitive performance
Expected Total Enrollment: 300
Secondary Outcomes: Cognitive performance
Expected Total Enrollment: 300
Study start: January 2006; Expected completion: May 2008
Last follow-up: December 2007; Data entry closure: February 2008
Eligibility
Ages Eligible for Study: 70 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Cognitively healthy, elective hip or knee replacement
Exclusion Criteria:
- Ongoing cholinergic treatment, dementia, delirium, acute physical illness
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00220896
Janine Diehl, M. D. +49-89-4140-4279 janine.diehl@lrz.tum.de
Germany
Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich, Munich, D-81675, Germany
Alexander Kurz, M. D. +49-89-4140-4285 alexander.kurz@lrz.tum.de
Janine Diehl, M. D., Principal Investigator
Janine Diehl, M. D., Principal Investigator
Study chairs or principal investigators
Janine Diehl, M. D., Principal Investigator, Dept. of Psychiatry, Technische Universitaet Muenchen
More Information
Study ID Numbers: PSYTUM1
Last Updated: September 21, 2005
Record first received: September 14, 2005
ClinicalTrials.gov Identifier: NCT00220896
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-27
Last Updated: September 21, 2005
Record first received: September 14, 2005
ClinicalTrials.gov Identifier: NCT00220896
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-27
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