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An Observational Study on the Relationship Between Tear Metabolomics and POD

Sponsor
The Second Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05548153
Collaborator
(none)
150
Enrollment
1
Location
7.3
Anticipated Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To explore the correlation between tear metabolomics and POD. The purpose of this study was to compare the results of tear metabolomics between POD and non-POD elderly patients undergoing abdominal surgery, to clarify the correlation between tear metabolomics and POD, and to find tear markers related to POD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study on the Relationship Between Tear Metabolomics and POD
    Actual Study Start Date :
    Aug 22, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative delirium during the 3 adys-follow-up after anesthetic resuscitation [From ending of the surgery to 3 days after anesthetic resuscitation]

      Postoperative delirium was tested with 3D-Confusion Assessment Method assessment scale or Confusion Assessment Method-intensive care unit assessment scale. The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.

    Secondary Outcome Measures

    1. Postoperative delirium in the postanesthesia care unit [From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes.]

      Postoperative delirium was tested with Confusion Assessment Method-intensive care unit assessment scale. Postoperative delirium was tested with Confusion Assessment Method-intensive care unit assessment scale. The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.

    2. Postoperative delirium on the first day after operation [9：00-10：00 and 15：00-16：00 on The first day after operation]

      Postoperative delirium was tested with 3D-Confusion Assessment Method assessment scale. The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.

    3. Postoperative delirium on the second day after operation [9：00-10：00 and 15：00-16：00 on The second day after operation]

      Postoperative delirium was tested with 3D-Confusion Assessment Method assessment scale. The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.

    4. Postoperative delirium on the third day after operation [9：00-10：00 and 15：00-16：00 on The third day after operation]

      Postoperative delirium was tested with 3D-Confusion Assessment Method assessment scale. The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age 65-90 years old;

    • ASA I-III;

    • patients who plan to undergo elective abdominal surgery under general anesthesia;

    • Volunteer to participate in this study and sign informed consent.

    Exclusion Criteria:

    • patients with known mental illness or lack of communication or cognitive impairment before operation;

    • severe vision, hearing, language impairment or other reasons unable to communicate with visitors;

    • severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;

    • long-term use of sedatives, antidepressants or alcoholism;

    • patients with severe postoperative complications and admitted to intensive care unit;

    • patients who refused or failed to complete the cognitive function test.

    • patients who could not cooperate with the study for any other reason

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University Chongqing Chongqing China 400010

    Sponsors and Collaborators

    • The Second Affiliated Hospital of Chongqing Medical University

    Investigators

    • Study Director: Huang He, MD, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Second Affiliated Hospital of Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT05548153
    Other Study ID Numbers:
    • tear and delirium
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 22, 2022
    Last Verified:
    Sep 1, 2022
    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
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of Sep 22, 2022