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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02413554
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Youn Young Chul, 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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Rivastigmine patch Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Dementia

Arm Intervention/treatment
Experimental: Patch applied patients

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
acetylcholine esterase inhibitor
Other Name: exelon patch

No Intervention: Patch non-applied patients
The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches.



Primary Outcome Measures :
  1. the number of participants with delirium [ Time Frame: up to 7th days ]
    investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants.


Secondary Outcome Measures :
  1. delirium severity using delirium rating scale [ Time Frame: up to 7th days ]
    to compare the severity of delirium in rivastigmine patch applied participants with non-applied



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413554


Sponsors and Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Investigators
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Principal Investigator: Young Chul Youn, MD, PhD Dept of Neurology, Chung-Ang University Hospital

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Responsible Party: Youn Young Chul, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT02413554    
Other Study ID Numbers: NR0001
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Youn Young Chul, Chung-Ang University Hosptial, Chung-Ang University College of Medicine:
acetylcholinesterase inhibitors
rivastigmine patch
post-operational delirium
Additional relevant MeSH terms:
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Dementia
Delirium
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents