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Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes

Sponsor
Han Yuan (Other)
Overall Status
Completed
CT.gov ID
NCT02992600
Collaborator
(none)
300
Enrollment
1
Location
7
Actual Duration (Months)
43.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor 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 [Patient Registry]
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes
    Actual Study Start Date :
    Dec 1, 2016
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Jul 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    study group

    300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests.
    control group

    30 healthy volunteers are enrolled for calculating the Z-scores of study group.

    Outcome Measures

    Primary Outcome Measures

    1. the neuropsychological test battery to measure cognitive function [1 day before surgery(baseline)]

    2. olfaction test to measure the sense of smell [1 day before surgery(baseline)]

    3. the neuropsychological tests to measure cognitive function [within 5 to 10 days (average of 7 days) after surgery]

    4. olfaction test to measure the sense of smell [within 5 to 10 days (average of 7 days) after surgery]

    Eligibility Criteria

    Criteria

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

    • Between 60 to 85 years old;

    • Undergoing non-cardiac and non-neurological surgery under general anesthesia;

    • Expected hospital stay ≥5 days;

    • American Society of Anesthesiologists class I or II.

    Exclusion criteria:

    • Mental or neurodegenerative diseases;

    • History of severe trauma or surgery within one year;

    • History of nasal or sinus illness or surgery;

    • Cold or influenza within 3 weeks;

    • Significant history of organ dysfunction;

    • Previous neuropsychological testing;

    • Difficulty to perform tests (including severe visual or auditory disorders);

    • Mini-Mental State Examination (MMSE) <24 points, <20 points if the participant only attended elementary school, or <17 points if the participant did not go to school.

    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

    • Han Yuan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han Yuan, Physician in Anesthesiology, Xuzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT02992600
    Other Study ID Numbers:
    • XYFY2016-KL018-01
    First Posted:
    Dec 14, 2016
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Han Yuan, Physician in Anesthesiology, 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 Jul 25, 2022