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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413554
• Other study ID #: NR0001
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2015
• Last updated: April 7, 2015
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Dementia

Intervention

Drug:
• Rivastigmine patch
acetylcholine esterase inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Outcome

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