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

Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery: a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04832568
Enrollment
200
Registered
2021-04-06
Start date
2021-06-17
Completion date
2027-12-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

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.

Interventions

None listed

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative deliriumAfter surgery through to postoperative day 7The 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

MeasureTime frameDescription
Relative power of each brain wavesDuring the stay of the patient in the operating room, after surgery through to postoperative day 7Electroencephalogram 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 deliriumAfter surgery through to postoperative day 7
Severity of deliriumAfter surgery through to postoperative day 7Delirium 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).
Worst daily pain scores at restAfter surgery through to postoperative day 7Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Worst daily pain scores with exertion (deep breathing and cough)After surgery through to postoperative day 7Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).
Length of stay in the Intensive Care Unit (ICU)through study completion, an average of 5 daysMeasured in days admitted in the ICU
Length of hospital staythrough study completion, an average of 10 daysMeasured in days admitted in the hospital

Countries

China

Contacts

CONTACTHua Zheng, Dr.
hzheng@hust.edu.cn0086-27-83663173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026