Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.

April 14, 2026 updated by: Xin Chen

Correlation Between Multiscale Entropy Analysis of Electroencephalograms and Postoperative Delirium Incidence.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Haikou, China
        • Recruiting
        • Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Elderly surgical patients undergoing general anesthesia.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly surgical patients undergoing general anaesthesia.
Device: Collect preoperative and intraoperative electroencephalogram data
Use Neuron-Spectrum-5-1 to collect preoperative and intraoperative electroencephalogram data.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xin Chen

Collaborators

Second Affiliated Hospital of Hainan Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

December 12, 2027

Study Completion (Estimated)

December 12, 2027

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUMU2H-EEGAMSE-CN-2025
  • No.823RC592 (Other Grant/Funding Number: Hainan Provincial Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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