Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery

October 30, 2021 updated by: General Hospital of Ningxia Medical University

Correlation of Electroencephalogram Epileptiform Discharges With Postoperative Delirium During Cardiac Surgery

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiac surgery patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of delirium after cardiac surgery
Time Frame: 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).
The first day after surgery
Incidence of delirium after cardiac surgery
Time Frame: The second day after surgery
Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.
The second day after surgery
Incidence of delirium after cardiac surgery
Time Frame: The third day after surgery
Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.
The third day after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epileptic discharge in electroencephalogram during cardiac surgery
Time Frame: Awake state after entering the operating room (baseline)
The electroencephalogram (EEG) was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist
Awake state after entering the operating room (baseline)
Epileptic discharge in electroencephalogram during cardiac surgery
Time Frame: 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
Start induction of anesthesia until leave the operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LN 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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