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

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Status and phase: Completed; Phase 4

Conditions: Delirium

Treatments: Drug: Rivastigmine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02413554

NR0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Patch applied patients

Experimental group

Description:

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.

Treatment:

Drug: Rivastigmine patch

Patch non-applied patients

No Intervention group

Description:

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