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

Phase 4

Completed

• Conditions: Delirium
• Interventions: Drug: Rivastigmine patch

• Registration Number: NCT02413554
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-03
• Status Verified: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-07
• Last Update Submitted: 2015-04-07
• Study First Posted: 2015-04-10
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patch applied patients	Rivastigmine patch	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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