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

NCT05001425 | Unknown

• 1 other identifier: LN 2021-1
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Brain Excitability; Postoperative Delirium; Cardiac Surgery

Keywords

Brain excitability; Postoperative Delirium; Abnormal EEG; Excitatory amino acid; Heart valve replacement surgery

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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)

• 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

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients undergoing heart valve replacement surgery with cardiopulmonary bypass

You may qualify if:

• ASA Ⅱ - Ⅲ;
• No cognitive impairment was assessed one day before surgery;
• Patients undergoing elective heart valve replacement under CPB and signed informed consent.

You may not qualify if:

• Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
• Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
• Inability to communicate with language impairment or major hearing or visual impairment;
• Liver function child-pugh Grade C, severe liver dysfunction;
• Severe renal insufficiency requires preoperative renal replacement therapy;
• A past history of intraoperative knowledge.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xinli Ni, doctor

  General Hospital of Ningxia Medical University

  STUDY CHAIR

Central Study Contacts

Xinli Ni, doctor

CONTACT

86-951-674-3252; xinlini6@nyfy.com.cn

Na Li, doctor

CONTACT

18509526253; anilln@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 12, 2021
• Study Start: July 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

CN (1)