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NCT Number: NCT04832568

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Hua Zheng, Dr.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: 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 outcomes

  1. Relative power of each brain waves

    Time frame: 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.

  2. Duration of delirium

    Time frame: After surgery through to postoperative day 7

  3. Severity of delirium

    Time frame: 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).

  4. Worst daily pain scores at rest

    Time frame: 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).

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

    Time frame: 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).

  6. Length of stay in the Intensive Care Unit (ICU)

    Time frame: through study completion, an average of 5 days

    Measured in days admitted in the ICU

  7. Length of hospital stay

    Time frame: through study completion, an average of 10 days

    Measured in days admitted in the hospital

Other outcomes

  1. Biomarkers

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

    Identify biomarkers (such as Ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), brain-derived neurotrophic factor (BDNF), and metalloproteases-9 (MMP-9) )of delirium and neural damage through changes in circulating plasma proteins and molecules

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zheng, Dr.

CONTACT

[email protected]

0086-27-83663173

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Apr 6, 2021
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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