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POCD: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.

Sponsor
Xuzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03084393
Collaborator
(none)
215
Enrollment
1
Location
14
Actual Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study on the Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    215 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
    Actual Study Start Date :
    Mar 1, 2017
    Actual Primary Completion Date :
    Apr 30, 2018
    Actual Study Completion Date :
    Apr 30, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    study group

    215 Male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. The investigators do the Mini-Mental score examination (MMSE) and neuropsychological tests 1 day before (baseline) and 1 week after surgery without safety issue. Patients will be divided into POCD and non-POCD groups according to the two times tests.
    non-surgical group

    The investigators enroll 30 healthy volunteers and do the Mini-Mental score examination (MMSE) and neuropsychological tests at 1 day (baseline) and1 week without safety issue. The exclusive purpose of the non-surgical group is to aid in the POCD calculation according to the ISPOCD 1 study definition.

    Outcome Measures

    Primary Outcome Measures

    1. the neuropsychological tests [1 day before surgery(baseline)]

      the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement Test,the Finger Tapping Test, the Word Fluency Test and the Building Block Test.

    2. Mini-Mental score examination [MMSE] [1 day before surgery(baseline)]

      Mini-Mental score examination [MMSE] used for screening of dementia

    3. the neuropsychological tests [within the first 7 days (plus or minus 2 days) after surgery]

      the neuropsychological tests to measure cognitive function, including the Trail Making Test, the Grooved Pegboard Test, the Digit Span Test, the Number-Symbol Replacement,the Test Finger Tapping Test, the Word Fluency Test and the Building Block Test.

    4. Mini-Mental score examination [MMSE] [within the first 7 days (plus or minus 2 days) after surgery]

      Mini-Mental score examination [MMSE] used for screening of dementia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Non-cardiac surgery patients;

    • Age is greater than or equal to 60 years old;

    • Han Nationality, mother tongue is chinese;

    • The MMSE score: Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;

    • The Geriatric Depression Scale (GDS) grade 1 or 2;

    • The important function without serious heart, brain, liver, kidney, lung and other organs;

    • The ASA class I or II;

    • The people signed informed consent.

    Exclusion Criteria:

    • The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.;

    • Had severe head and face disease, trauma history or history of surgery;

    • The serious body disease and tobacco, wine and other substance abuse history;

    • The presence of malignant tumor with shorter survival disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China

    Sponsors and Collaborators

    • Xuzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT03084393
    Other Study ID Numbers:
    • XYFY2017-KL004-01
    First Posted:
    Mar 20, 2017
    Last Update Posted:
    Mar 11, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University
    non-cardiac surgery
    Postoperative Cognitive Dysfunction
    Additional relevant MeSH terms:
    Postoperative Cognitive Complications
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Mar 11, 2020