Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery

NCT04832568 | Recruiting

• 1 other identifier: TJMZK202101
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  The incidence of postoperative delirium was determined according to the Confusion Assessment Method (CAM) diagnostic algorithm. The algorithm consists of four clinical criteria: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. To define a patient as having delirium, both the first and the second criteria have to be present, as well as either the third or the fourth criteria. The CAM-ICU will be used for patients who are intubated in the postoperative period.

  After surgery through to postoperative day 7

Secondary Outcomes (7)

• Relative power of each brain waves

  During the stay of the patient in the operating room, after surgery through to postoperative day 7

• Duration of delirium

  After surgery through to postoperative day 7

• Severity of delirium

  After surgery through to postoperative day 7

• Worst daily pain scores at rest

  After surgery through to postoperative day 7

• Worst daily pain scores with exertion (deep breathing and cough)

  After surgery through to postoperative day 7

Other Outcomes (1)

• Biomarkers

  before and after surgery in operating room, after surgery through to postoperative day 7

Study Arms (2)

Delirium is determined by CAM or CAM-ICU score

No delirium is determined by CAM or CAM-ICU score

Eligibility Criteria

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

Study Population

Patients undergoing cardiovascular surgery

You may qualify if:

• age of at least 18 years
• normal cognitive function at the time of enrollment evidenced by a Mini-Mental State Examination (MMSE) score of more than 24 of 30
• Chinese Mandarin as the native language
• providing informed consent

You may not qualify if:

• pre-existing delirium assessed according to the Confusion Assessment Method (CAM)
• history of neurological or psychiatric disease
• impaired vision or auditory function which may effect the assessments
• unwillingness to participate in the study

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Hua Zheng, Dr.

CONTACT

0086-27-83663173; hzheng@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 6, 2021
• Study Start: June 17, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)