NCT06692309

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

May 22, 2024

Last Update Submit

May 25, 2025

Conditions

Cardiovascular SurgeryPerioperative Neurocognitive Disorders

Keywords

Perioperative Neurocognitive Disorders;Electroencephalography

Outcome Measures

Primary Outcomes (1)

  • The predictive value of preoperative Electroencephalography features in patients with postoperative cognitive dysfunction following cardiovascular surgery

    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).

    2025.08

Secondary Outcomes (2)

  • The predictive value of preoperative Electroencephalography features in patients with postoperative delirium following cardiovascular surgery

    2025.08

  • Electroencephalography features in patients with postoperative delirium

    2025.08

Study Arms (2)

Perioperative Neurocognitive Disorders

Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) . 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).

Procedure: cardiovascular surgery

No-Perioperative Neurocognitive Disorders

Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) . 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).

Procedure: cardiovascular surgery

Interventions

cardiovascular surgeryPROCEDURE

Heart bypass surgery; Heart valve replacement surgery

No-Perioperative Neurocognitive DisordersPerioperative Neurocognitive Disorders

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

Cardiovascular Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Anshi Wu, doctor

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changwei Wei, doctor

CONTACT

13810678936changwei.wei@ccmu.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

November 18, 2024

Study Start

March 1, 2023

Primary Completion

August 31, 2025

Study Completion

February 28, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations

CN(1)