Donepezil in Preventing Delirium in Hospitalized Elderly
The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Preventing Delirium in Hospitalized Elderly|
- 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
|Study Start Date:||July 2004|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|