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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02550626
Collaborator
(none)
106
Enrollment
1
Location
10
Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    106 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Aug 1, 2016
    Actual Study Completion Date :
    Aug 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Delirium

    occurrence of post-operative delirium
    No delirium

    no presence of post-operative delirium

    Outcome Measures

    Primary Outcome Measures

    1. existence of anosomia [A day before operation]

      During 72hrs after spine surgery, investigator will observe occurrence of post-operative delirium, and analysis difference of anosmia symptoms before operation between 2 groups. The cross-cultural smell identification test will be used for measure of anosmia. investigator define anosmia as less than 4 score on the cross-cultural smell identification test. This study is not interventional study, because measure of anosmia by smell kit will not develop post-operation delirium more. (investigator will classify our patients into normosmia if the CCSIT score is 9 or higher, and hyposmia if the CCSIT score is 6 or less. Patients whose CCSIT scores are 7 or 8 will be regarded as borderline.).

    Secondary Outcome Measures

    1. existence of constipation [A day before operation]

      Questionnaire (Constipation scoring system (Agachanet al., 1996) & Rome III Questionnaire (Constipation : Yes/No)

    2. existence of orthostatic hypotension [A day before operation]

      Check 3 position BP (define orthostatic hypotension - sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg within 3 min of standing, / Questionnaire (orthostatic hypotension symptom assessment & Orthostatic hypotension daily activities scale) (orthostatic hypotension: Yes/No)

    3. existence of insomnia [A day before operation]

      Questionnaire (Epworth Sleepiness Scale (ESS) : total score 0-24)

    4. existence of depression [A day before operation]

      Questionnaire (Beck depression inventory, total score 0-63)

    5. existence of anxiety [A day before operation]

      Questionnaire (The Parkinson Anxiety Scale, total score 0-48)

    6. existence of REM sleep behavior disorder [A day before operation]

      Questionnaire (RBD screening questionnaire, total score 0-13) :These questionnaires & checking 3-position BP will not effect the occurence of post-operation delirium

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurology, Yonsei University College of Medicine Seoul Seou Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02550626
    Other Study ID Numbers:
    • 4-2015-0365
    First Posted:
    Sep 15, 2015
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Yonsei University
    delirium
    alpha synucleinopathy
    spine surgery
    Additional relevant MeSH terms:
    Delirium
    Synucleinopathies

    Study Results

    No Results Posted as of Feb 15, 2019