Back to resultsRivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.
Primary Purpose
Delirium
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rivastigmine patch
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring acetylcholinesterase inhibitors, rivastigmine patch, post-operational delirium
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patch applied patients
Patch non-applied patients
Arm 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.
The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches.
Outcomes
Primary Outcome Measures
the number of participants with delirium
investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants.
Secondary Outcome Measures
delirium severity using delirium rating scale
to compare the severity of delirium in rivastigmine patch applied participants with non-applied
Full Information
NCT ID
NCT02413554
First Posted
April 2, 2015
Last Updated
April 7, 2015
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02413554
Brief Title
Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.
Official Title
Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
acetylcholinesterase inhibitors, rivastigmine patch, post-operational delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patch applied patients
Arm Type
Experimental
Arm 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.
Arm Title
Patch non-applied patients
Arm Type
No Intervention
Arm Description
The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine patch
Other Intervention Name(s)
exelon patch
Intervention Description
acetylcholine esterase inhibitor
Primary Outcome Measure Information:
Title
the number of participants with delirium
Description
investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants.
Time Frame
up to 7th days
Secondary Outcome Measure Information:
Title
delirium severity using delirium rating scale
Description
to compare the severity of delirium in rivastigmine patch applied participants with non-applied
Time Frame
up to 7th days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Chul Youn, MD, PhD
Organizational Affiliation
Dept of Neurology, Chung-Ang University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.
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