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

Study Overview
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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.

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.

Official Title
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Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.

Conditions
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Delirium

Intervention / Treatment
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* Drug: Rivastigmine patch


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patch applied patients<br>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. | Drug: Rivastigmine patch<br>* acetylcholine esterase inhibitor<br>* Other names: exelon patch;|
| No Intervention: Patch non-applied patients<br>The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of participants with delirium | investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants. | up to 7th days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium severity using delirium rating scale | to compare the severity of delirium in rivastigmine patch applied participants with non-applied | up to 7th days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetylcholinesterase inhibitors, rivastigmine patch, post-operational delirium