Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass

Cardiac Surgery Clinical Trial

Official title:

Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001425
• Other study ID #: LN 2021-1
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: August 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 explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium

Description:

Delirium is the most common surgical patients postoperative complications of brain dysfunction. Delirium is a kind of consciousness attention and cognitive function changes of acute brain dysfunction, with volatility and reversibility of postoperative delirium (POD), increased hospital costs and length of hospital stay and mortality rate, and can lower the quality of life, lead to long-term postoperative cognitive dysfunction and dementia. The incidence of postoperative cognitive dysfunction in patients undergoing cardiac valve replacement under cardiopulmonary bypass (CPB) can be as high as 44-53%. However, since the specific mechanism of POD is still not clear, there is still a lack of effective prevention and treatment measures. Therefore, early detection and identification are helpful for the early treatment of POD.When brain injury occurs, the levels of excitatory neurotransmitters (glutamate and aspartate) will rise in a short period of time, and the high concentration of glutamate causes excessive intracellular calcium flow, causing cellular calcium overload, and generating excitatory cytotoxic effects. And abnormal electroencephalogram (EEG) is a kind of due to brain excitability/inhibitory amino acid imbalance caused by brain excitability increased result in abnormal discharge mode, can affect cognitive awareness and activities. Increased brain excitability is harmful to the potential, should avoid to happen. At present, the relationship between brain excitability and POD is still in exploring. Therefore, it is important to clarify the correlation between brain excitability and POD in patients undergoing cardiac valve replacement under CPB for improving the pathogenesis of POD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• 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 ? - ?;

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

3. Patients undergoing elective heart valve replacement under CPB 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

• Cardiac Surgery
• Delirium
• 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	The 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	The 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 second day after surgery
Primary	The 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 third day after surgery
Primary	Abnormal EEG during surgery	The EEG was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist, to identify whether the EEG of the patient was epileptic discharge and burst suppression during anesthesia	Complete EEG information from entry to exit of the operating room
Primary	Plasma excitatory amino acid levels	Venous blood 5ml was collected and centrifuged (3500r/min,10min),sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.	Before the operation after entering the operating room (baseline)
Primary	Plasma excitatory amino acid levels	Venous blood 5ml was collected and centrifuged (3500r/min,10min),sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.	Immediately after surgery
Primary	Plasma excitatory amino acid levels	Venous blood 5ml was collected and centrifuged (3500r/min,10min),sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.	24 hours after surgery