Clinical trial NCT06692309: Exploring the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders Following Cardiovascular Surgery
Official title: To Explore the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders in Patients Undergoing Cardiovascular Surgery Under General Anaesthesia: a Single-centre Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Surgery
Perioperative Neurocognitive Disorders
Keywords: Perioperative Neurocognitive Disorders;Electroencephalography
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. older than 60 years
2. ASA grade: I-III
3. undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia
4. able to complete cognitive function tests

Brief summary: To explore the predictive value of Electroencephalography features in Perioperative Neurocognitive Disorders in patients undergoing cardiovascular surgery under general anesthesia

Detailed description: Data was acquired on the ward using a 10-20 system with a standard 32-channel EEG cap and an EEG instrument (BP Company, Gilching, Germany). Patients were tested using cognitive assessment scales before and after surgery.

Cognitive levels were assessed 1 day before surgery and 1 week after surgery (7±2 days) using the Montreal Cognitive Assessment (MoCA) . Patients were followed up one month (30±2 days) after surgery using the Telephone version of the Montreal Cognitive Assessment Scale (T-MoCA).

Preoperative and postoperative electroencephalography brain network-related indexes (such as cluster coefficient, small world index, etc.) in patients with PND will be included in the analysis.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia
3. ASA grade: II-IV
4. older than 60 years
5. Able to complete cognitive function tests

Exclusion criteria:

1. history of severe neurological diseases and psychiatric diseases
2. history of drug abuse
3. severe hearing or vision impairment
4. preoperative delirium
5. serious adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
6. patients undergoing secondary surgery in a short period
7. participation in concurrent clinical trials

Primary outcomes:
measure: The predictive value of preoperative Electroencephalography features in patients with postoperative cognitive dysfunction following cardiovascular surgery
timeFrame: 2025.08
Secondary outcomes:
measure: The predictive value of preoperative Electroencephalography features in patients with postoperative delirium following cardiovascular surgery
timeFrame: 2025.08
measure: Electroencephalography features in patients with postoperative delirium
timeFrame: 2025.08
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Anshi Wu, doctor
role: PRINCIPAL_INVESTIGATOR
References: