Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery

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: Recruiting
• Conditions: Postoperative Delirium; Electroencephalogram

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: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium after cardiac 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	Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.	The second day after surgery
Incidence of delirium after cardiac surgery	Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.	The third day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epileptic discharge in electroencephalogram during cardiac surgery	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	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

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Electroencephalogram; Cardiac surgery; Epileptiform discharges; Postoperative delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID 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