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

ConditionDelirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients undergoing cardiovascular surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Delirium is determined by CAM or CAM-ICU score
Group B: No delirium is determined by CAM or CAM-ICU score

Trial outcomes

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.

Time frame
After surgery through to postoperative day 7

Secondary outcomes

1

Relative power of each brain waves

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.

Time frame
During the stay of the patient in the operating room, after surgery through to postoperative day 7
2

Duration of delirium

Time frame
After surgery through to postoperative day 7
3

Severity of delirium

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).

Time frame
After surgery through to postoperative day 7
4

Worst daily pain scores at rest

Pain scores will be collected three times daily using a numeric rating scale (0, no pain, to 10, worst possible pain).

Time frame
After surgery through to postoperative day 7

Other outcomes

1

Biomarkers

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.