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

NCT02413554 | Completed Phase 4 DMC

• 1 other identifier: NR0001
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium

Keywords

acetylcholinesterase inhibitors; rivastigmine patch; post-operational delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• delirium severity using delirium rating scale

  up to 7th days

Study Arms (2)

Patch applied patients

EXPERIMENTAL

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

Patch non-applied patients

NO INTERVENTION

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

Interventions

Rivastigmine patch DRUG

acetylcholine esterase inhibitor

Also known as: exelon patch

Patch applied patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Young Chul Youn, MD, PhD

  Dept of Neurology, Chung-Ang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 10, 2015

Record last verified: 2015-04