Correlation Between Perioperative EEG Variability and Pos... | NCT07323940

Studies
Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.

NCT07323940

Sponsor

Xin Chen

Status

Recruiting

Last Update Posted

Apr 16, 2026Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Delirium - Postoperative

Interventions

Collect preoperative and intraoperative electroencephalogram data

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
No.823RC592	Other Grant/Funding Number	Hainan Provincial Natural Science Foundation of China

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2025Actual

Primary Completion Date

Dec 12, 2027Estimated

Completion Date

Dec 12, 2027Estimated

First Submitted Date

Dec 24, 2025

First Submission Date that Met QC Criteria

Dec 24, 2025

First Posted Date

Jan 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xin Chen, Associate Researcher,the Second Affiliated Hospital of Hainan Medical University, Hainan Medical CollegeSponsor-Investigator

Lead Sponsor

Xin ChenOTHER

Collaborators

Name	Class
Second Affiliated Hospital of Hainan Medical College	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This clinical study aims to investigate whether multiscale entropy analysis of electroencephalogram data can distinguish between ordinary elderly surgical patients and elderly patients with postoperative delirium.This study may help identify postoperative delirium in surgical patients at an early stage.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly surgical patients undergoing general anaesthesia.			Device: Collect preoperative and intraoperative electroencephalogram data

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collect preoperative and intraoperative electroencephalogram data	Device	Use Neuron-Spectrum-5-1 to collect preoperative and intraoperative electroencephalogram data.	Elderly surgical patients undergoing general anaesthesia.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative delirium	Using the 3D-CAM scale to assess postoperative delirium in surgical patients.	Within seven days after surgery(Day 0-7)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing general anaesthesia with single-lumen endotracheal tube placement;
Age ≥65 years, gender unrestricted, body mass index (BMI) 18-28 kg/m²;
Normal mouth opening and head/neck mobility;
Pre-anaesthesia American Society of Anaesthesiologists (ASA) physical status classification of I or II and Mallampati airway classification of I or II.

Exclusion Criteria:

Individuals with psychiatric disorders, literacy issues, or communication difficulties who are unable to cooperate with POD screening;
Patients with severe lesions in vital organs, such as the heart, lungs, brain, liver or kidneys.
Those undergoing cardiac or neurosurgical procedures during this admission;
A history of alcohol abuse or recent use of sedatives or opioids;
haemoglobin <100 g/L;
Participation in any clinical research studies within the past 3 months.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly surgical patients undergoing general anesthesia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fu Dr.chen	Contact	8617378224751		Dr_chen1699@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University	Recruiting	Haikou			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34322079	Result	Xu N, Li LX, Wang TL, Jiao LQ, Hua Y, Yao DX, Wu J, Ma YH, Tian T, Sun XL. Processed Multiparameter Electroencephalogram-Guided General Anesthesia Management Can Reduce Postoperative Delirium Following Carotid Endarterectomy: A Randomized Clinical Trial. Front Neurol. 2021 Jul 12;12:666814. doi: 10.3389/fneur.2021.666814. eCollection 2021.
23992774

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations