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

Recruiting

• Conditions: Delirium

• Registration Number: NCT04832568
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-06
• Study Start: 2021-06-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	After surgery through to postoperative day 7	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.

Secondary Outcome Measures

Name	Time	Method
Worst daily pain scores at rest	After surgery through to postoperative day 7	Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Length of hospital stay	through study completion, an average of 10 days	Measured in days admitted in the hospital
Relative power of each brain waves	During the stay of the patient in the operating room, after surgery through to postoperative day 7	Electroencephalogram data were acquired using a 32-channel electroencephalogram recording system (Brain Products, Germany). A 5 min, baseline, eyes-closed recording was conducted at the preoperative holding room when the patient was at rest. Recording of electroencephalogram was commenced before the start of anesthetic induction and was stopped before discharge of the patient from the operating room. We defied delta (1 to 3 Hz), theta (4 to 7 Hz), alpha (8 to 12 Hz), and beta (13 to 40 Hz) frequency bands. And then, the relative power of each frequency bands to the total power of the sum is calculated.
Duration of delirium	After surgery through to postoperative day 7
Severity of delirium	After surgery through to postoperative day 7	Delirium severity is evaluated both as the peak (highest) and sum Confusion Assessment Method - Severity (CAM-S) score over all hospital days. The CAM-S includes two forms: a Short Form (CAM-S Short Form, based on the 4-item algorithm, the sum of score ranging from 0 to 7, with 7 being the most severe) and a Long Form (CAM-S Long Form, based on the 10-item CAM instrument, the sum of score ranging from 0 to 19, with 19 being the most severe).
Length of stay in the Intensive Care Unit (ICU)	through study completion, an average of 5 days	Measured in days admitted in the ICU
Worst daily pain scores with exertion (deep breathing and cough)	After surgery through to postoperative day 7	Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China