Donepezil in Preventing Delirium in Hospitalized Elderly
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|ClinicalTrials.gov Identifier: NCT00182884|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 3, 2008
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications Delirium||Drug: Donepezil||Phase 4|
Delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. Up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. These individuals often stay in the hospital longer, have more complications, and are more likely to die. Early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. Donepezil is currently being used to treat memory loss in patients with Alzheimer's disease.
This study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. Participants will be randomized to receive either Donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery.
All material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. The Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS) will be used to evaluate the effect of Donepezil on delirium incidence and severity. Other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Preventing Delirium in Hospitalized Elderly|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
- Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge
- delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)
- Cognitive status as measured by the Mini Mental Status Exam (MMSE)
- behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)
- length of stay in hospital postoperatively
- discharge site
- adverse effects
- use of psychotropic medications
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): NCT00182884
|United States, Indiana|
|Methodist Hospital, Clarian Health Partners|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Malaz Boustani, MD, MPH||Regenstrief Institute, Indiana University Center for Aging Research|