Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery

Postoperative Delirium Clinical Trial

Official title:

Correlation of Electroencephalogram Epileptiform Discharges With Postoperative Delirium During Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943939
• Other study ID #: LN 2021
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2021
• Source: General Hospital of Ningxia Medical University
• Contact: Xinli Ni, doctor
• Phone: 86-951-674-3252
• Email: xinlini6[@]nyfy.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Electroencephalogram
• Postoperative Delirium

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of delirium after cardiac surgery	Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.	The second day after surgery
Primary	Incidence of delirium after cardiac surgery	Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.	The third day after surgery
Secondary	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)
Secondary	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