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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02413554

Enrollment

Registered

2015-04-10

Start date

2013-04-30

Completion date

2015-04-30

Last updated

2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

acetylcholinesterase inhibitors, rivastigmine patch, post-operational delirium

Brief summary

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

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.

Interventions

DRUGRivastigmine patch

acetylcholine esterase inhibitor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026