NCT07323940

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Dec 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 12, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2027

Last Updated

April 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 24, 2025

Last Update Submit

April 14, 2026

Conditions

Delirium - Postoperative

Keywords

Postoperative deliriumelectroencephalogramMultiscale Entropy

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative delirium

    Using the 3D-CAM scale to assess postoperative delirium in surgical patients.

    Within seven days after surgery(Day 0-7)

Study Arms (1)

Elderly surgical patients undergoing general anaesthesia.

Device: Collect preoperative and intraoperative electroencephalogram data

Interventions

Collect preoperative and intraoperative electroencephalogram dataDEVICE

Use Neuron-Spectrum-5-1 to collect preoperative and intraoperative electroencephalogram data.

Elderly surgical patients undergoing general anaesthesia.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly surgical patients undergoing general anesthesia.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University

Haikou, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34322079RESULT

  • Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

    PMID: 23992774RESULT

  • Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Aceto P, Audisio R, Cherubini A, Cunningham C, Dabrowski W, Forookhi A, Gitti N, Immonen K, Kehlet H, Koch S, Kotfis K, Latronico N, MacLullich AMJ, Mevorach L, Mueller A, Neuner B, Piva S, Radtke F, Blaser AR, Renzi S, Romagnoli S, Schubert M, Slooter AJC, Tommasino C, Vasiljewa L, Weiss B, Yuerek F, Spies CD. Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients. Eur J Anaesthesiol. 2024 Feb 1;41(2):81-108. doi: 10.1097/EJA.0000000000001876. Epub 2023 Aug 30.

    PMID: 37599617RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Fu Dr.chen

CONTACT

8617378224751Dr_chen1699@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Researcher,the Second Affiliated Hospital of Hainan Medical University

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 7, 2026

Study Start

December 12, 2025

Primary Completion (Estimated)

December 12, 2027

Study Completion (Estimated)

December 12, 2027

Last Updated

April 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)