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Completed

NCT Number: NCT00182884

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Methodist Hospital, Clarian Health Partners

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil

Drug

Primary outcomes

  1. Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge

  2. delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)

Secondary outcomes

  1. Cognitive status as measured by the Mini Mental Status Exam (MMSE)

  2. behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)

  3. length of stay in hospital postoperatively

  4. discharge site

  5. adverse effects

  6. use of psychotropic medications

Sponsors and collaborators

Lead sponsor

Indiana University Health

Other

Registry information

Official study title

Preventing Delirium in Hospitalized Elderly

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Mar 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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