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Recruiting NCT07323940

Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.

Observational Delirium - Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collect preoperative and intraoperative electroencephalogram data.
Who it may be relevant to
Registry conditions: Delirium - Postoperative. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of postoperative delirium [Time frame: Within seven days after surgery(Day 0-7)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University — Haikou

Publications

  • 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 34322079
  • 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 23992774
  • 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 Anaesth PMID 37599617

Identifiers

NCT: NCT07323940 · HUMU2H-EEGAMSE-CN-2025 · No.823RC592

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗