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RecruitingNCT07323940Updated Apr 16, 2026

Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.

An observational study in Delirium - Postoperative, sponsored by Xin Chen. Recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Xin Chen · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
65 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Delirium - Postoperative

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Keywords

  • Postoperative delirium
  • electroencephalogram
  • Multiscale Entropy
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In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's planned enrollment of 90 is below the median of 164 across 280 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Xin Chen is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Elderly surgical patients undergoing general anesthesia.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
8 Days
Patient registry
Yes

Groups and cohorts

  • Elderly surgical patients undergoing general anaesthesia.

    Device: Collect preoperative and intraoperative electroencephalogram data

Interventions

  • DeviceCollect preoperative and intraoperative electroencephalogram data

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

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What researchers measure

Primary outcomes

  1. Incidence of postoperative delirium

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

    Time frame: Within seven days after surgery(Day 0-7)

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Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
    Haikou, China
    Recruiting
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References and documents

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. PubMed 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. PubMed 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 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. PubMed 37599617 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07323940
Lead sponsor
Xin Chen
Collaborators
Second Affiliated Hospital of Hainan Medical College
Responsible party
Xin Chen (Associate Researcher,the Second Affiliated Hospital of Hainan Medical University, Hainan Medical College) — Sponsor-investigator
First posted
Jan 7, 2026
Start date
Dec 12, 2025
Primary completion
Dec 12, 2027 (estimated)
Completion
Dec 12, 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

Fu Dr.chen
Contact
Dr_chen1699@163.com
8617378224751

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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