Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182884
Status:
COMPLETED
Last Update Posted:
2008-03-03
First Post:
2005-09-09
Brief Title:
Donepezil in Preventing Delirium in Hospitalized Elderly
Sponsor:
Indiana University Health
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Preventing Delirium in Hospitalized Elderly
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VFR-161 | None | None | None |