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Completed

NCT Number: NCT02413554

Rivastigmine Patch Effect on the Post-operative Delirium 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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rivastigmine patch

Drug

acetylcholine esterase inhibitor

Other names: exelon patch

Primary outcomes

  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 outcomes

  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

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Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 10, 2015
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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