Clincosm LogoSign in Get a demo

Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04943939
Collaborator
(none)
60
Enrollment
1
Location
17
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cardiac surgery under cardiopulmonary bypass (CPB) as a result of the surgery itself great trauma and CPB this special process can lead to cerebral hypoperfusion, cerebral ischemia, increased in patients with postoperative neurological complications, the incidence of postoperative cognitive dysfunction can up to 44-53%.Postoperative delirium (POD) is not only increase the incidence of postoperative cognitive dysfunction forward, affect the quality of postoperative recovery and increased hospital costs, also associated with postoperative mortality. Although the clinical use of different drugs and technology improve the POD, but due to the mechanism is still unclear, is still lack of effective control measures. Electroencephalogram (EEG) can measure the cerebral cortex and subcortical local potential activities, to reflect the activities of the neurons in the brain. CPB can cause the abnormal vibration of brain waves, epileptiform discharges is the result of abnormal discharge of brain neurons, which is correlated with the occurrence of cognitive dysfunction.But whether EEG epileptiform discharges is related to the POD is uncertain.While epileptic seizures can be treated with anticonvulsant drugs, so the detection and treatment of early epileptic seizures may have important clinical significance for the occurrence of POD. Therefore, the main purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD, offer the theoretical foundation for delirium early warning and prevention.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation of Electroencephalogram Epileptiform Discharges With Postoperative Delirium During Cardiac Surgery
    Actual Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of delirium after cardiac surgery [The first day after surgery]

      Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).

    2. Incidence of delirium after cardiac surgery [The second day after surgery]

      Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.

    3. Incidence of delirium after cardiac surgery [The third day after surgery]

      Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.

    Secondary Outcome Measures

    1. Epileptic discharge in electroencephalogram during cardiac surgery [Awake state after entering the operating room (baseline)]

      The electroencephalogram (EEG) was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist

    2. Epileptic discharge in electroencephalogram during cardiac surgery [Start induction of anesthesia until leave the operating room]

      The electroencephalogram (EEG) was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. ASA II-III;

    2. No cognitive impairment was assessed one day before surgery;

    3. Patients undergoing elective CPB cardiac surgery(valvular heart surgery and coronary bypass surgery) and signed informed consent.

    Exclusion Criteria:

    1. Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;

    2. Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;

    3. Inability to communicate with language impairment or major hearing or visual impairment;

    4. Liver function child-pugh Grade C, severe liver dysfunction;

    5. Severe renal insufficiency requires preoperative renal replacement therapy;

    6. A past history of intraoperative knowledge.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004

    Sponsors and Collaborators

    • General Hospital of Ningxia Medical University

    Investigators

    • Study Chair: Xinli Ni, doctor, General Hospital of Ningxia Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Hospital of Ningxia Medical University
    ClinicalTrials.gov Identifier:
    NCT04943939
    Other Study ID Numbers:
    • LN 2021
    First Posted:
    Jun 29, 2021
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by General Hospital of Ningxia Medical University
    Electroencephalogram
    Epileptiform discharges
    Postoperative delirium
    Cardiac surgery
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of Nov 2, 2021