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

April 7, 2015 updated by: Youn Young Chul, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 7th days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 7th days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Investigators

  • Principal Investigator: Young Chul Youn, MD, PhD, Dept of Neurology, Chung-Ang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (ESTIMATE)

April 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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