Exploring the Relationship Between Alpha-synucleinopathy Related Non-motor Symptom and Post-op. Delirium in Elderly Patients With Spine Surgery

NCT ID: NCT02550626

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-08-31

Brief Summary

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Hypothesis is that the presence of a-synucleinopathy related non motor symptoms could be predictive factor for post-operative delirium. During 72hrs after spine surgery, investigator will observe occurrence of post-operative delirium, and analysis difference of a-synucleinopathy related non motor symptoms between 2 groups.

Detailed Description

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Postoperative delirium appear approximately 10-70% of patients older than 65 yrs undergoing surgery and it is strongly associated with poor surgical outcome. The clinical characteristics of postoperative delirium are fluctuating attention, visual hallucination, disorganized thought and alter sleep-wake cycles. This is quite similar to core features of α-synuclein-related cognitive disorders such as parkinson's disease dementia and dementia with lewy body. At that point, investigator thought that postoperative delirium is preclinical stage of a-synucleinopathy. In other words, a-synuclein related disorders and postoperative delirium may share an underlying neurochemical change in their pathogenesis.

investigator will recruit age 65 and older patients scheduled to perform spine surgery. The pre-operative evaluation include neurologic exam, baseline cognitive function and a-synucleinopathy related non motor symptoms through Questionnaires.

Conditions

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Post-operation Delirium Alpha-synucleinopathy Related Non-motor Symptom

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Delirium

occurrence of post-operative delirium

No interventions assigned to this group

No delirium

no presence of post-operative delirium

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age 65 and older patients
2. Scheduled to perform spine surgery in severance hospital

Exclusion Criteria

1. Previous delirium history
2. Previous chemotherapy or radiotherapy within 1yr due to underlying cancer.
3. Severe hepatic/renal dysfunction
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurology, Yonsei University College of Medicine

Seoul, Seou, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0365

Identifier Type: -

Identifier Source: org_study_id

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