Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Investigators aimed to establish the preventive effect of the cholinesterase inhibitor, rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation in patients at risk of dementia.

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Detailed Description

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Investigators evaluated the delirium prevention effect of rivastigmine patch in patients with femur neck fracture and cognitive impairment. Investigators measured the frequency and severity of post-operation delirium in the patch applied and non-applied subjects.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patch applied patients

The investigators had enrolled consecutively the patients who were going to operation after femur neck fracture.

Participants were applied the 5 unit rivastigmine patches from 3 days before and 7 days after the femur neck operation.

Group Type EXPERIMENTAL

Rivastigmine patch

Intervention Type DRUG

acetylcholine esterase inhibitor

Patch non-applied patients

The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rivastigmine patch

acetylcholine esterase inhibitor

Intervention Type DRUG

Other Intervention Names

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exelon patch

Eligibility Criteria

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Inclusion Criteria

* Consecutively enrolled the patients who is going to operation after femur neck fracture.
* Patients agree to the informed consent.

Exclusion Criteria

* depressive mood and their geriatric depression scale is over 6 / 15.
* Their Korean version MMSE(minimental status examination) are over 25, or global dementia scale (GDS) are under 3 or over 5.
* any delirious state at pre-operation period by DSM IV and CAM (Confusion Assessment Method)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No