Donepezil in Preventing Delirium in Hospitalized Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Complications Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Donepezil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Community-dwelling individuals aged 65 or older
* Admitted to Methodist Hospital for surgical repair of hip fracture
* No evidence of delirium at admission to hospital
* MMSE total score below 24 points after adjustment for education and age
* Consent to participate in the study

Exclusion Criteria

* Severely demented as defined by MMSE score below 10
* Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months
* Multiple trauma or pathological fractures
* Aphasic, legally blind, or deaf
* Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery
* Allergy to Donepezil

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes