Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery

NCT04943939 | Unknown

• 1 other identifier: LN 2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Electroencephalogram; Postoperative Delirium

Keywords

Electroencephalogram; Epileptiform discharges; Postoperative delirium; Cardiac surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Epileptic discharge in electroencephalogram during cardiac surgery

  Awake state after entering the operating room (baseline)

• Epileptic discharge in electroencephalogram during cardiac surgery

  Start induction of anesthesia until leave the operating room

Eligibility Criteria

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

Study Population

Cardiac surgery patients

You may qualify if:

• ASA II-III;
• No cognitive impairment was assessed one day before surgery;
• Patients undergoing elective CPB cardiac surgery(valvular heart surgery and coronary bypass surgery) 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: May 20, 2021
• First Posted: June 29, 2021
• Study Start: July 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-06

Locations

CN (1)