- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06692309
Exploring the Predictive Value of Electroencephalography Features in Perioperative Neurocognitive Disorders Following Cardiovascular Surgery
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Changwei Wei, doctor
- Phone Number: +86 13810678936
- Email: changwei.wei@ccmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chao Yang Hospital
-
Contact:
- Changwei Wei
- Phone Number: +86 13810678936
- Email: changwei.wei@ccmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- older than 60 years
- ASA grade: I-III
- undergoing coronary artery bypass surgery or valve replacement surgery under general anaesthesia
- able to complete cognitive function tests
Description
Inclusion Criteria:
- 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
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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). |
Heart bypass surgery; Heart valve replacement 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). |
Heart bypass surgery; Heart valve replacement surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The predictive value of preoperative Electroencephalography features in patients with postoperative cognitive dysfunction following cardiovascular surgery
Time Frame: 2025.08
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The predictive value of preoperative Electroencephalography features in patients with postoperative delirium following cardiovascular surgery
Time Frame: 2025.08
|
Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) .
|
2025.08
|
|
Electroencephalography features in patients with postoperative delirium
Time Frame: 2025.08
|
Electroencephalography was collected in delirium patients one week(7±2 days) after surgery. Postoperative delirium was assessed using the confusion assessment method or the confusion assessment method for the intensive care unit (CAM/CAM-ICU) . Preoperative and postoperative electroencephalography brain network-related indexes (such as cluster coefficient, small world index, etc.) in patients with postoperative delirium will be included in the analysis. |
2025.08
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anshi Wu, doctor, Beijing Chao Yang Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DXK2022-ke-487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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