Actively Recruiting

Age: 65Years +
All Genders
Healthy Volunteers
ID07323940

Correlation Between Multiscale Entropy Analysis of Electroencephalograms and Postoperative Delirium Incidence

Led by Xin Chen · Updated on 2026-04-16

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

X

Xin Chen

Lead Sponsor

S

Second Affiliated Hospital of Hainan Medical College

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying whether multiscale entropy analysis of electroencephalogram (EEG) data can help distinguish between ordinary elderly surgical patients and those who develop postoperative delirium. The study aims to identify postoperative delirium early in patients aged 65 and older undergoing surgery with general anesthesia. The sponsor leading this observational study is Xin Chen. Participants will have their EEG data collected before and during surgery using a device called Neuron-Spectrum-5-1. The study focuses on elderly patients undergoing general anesthesia with specific airway management criteria. There are no drug treatments involved as this is an observational study that monitors brain activity to find patterns linked to delirium. During the study, researchers will observe participants for signs of postoperative delirium within seven days after surgery. They will analyze the EEG data collected and monitor patients closely to evaluate the incidence of delirium. Participation includes EEG recording and standard surgical care, with follow-up assessments to track delirium symptoms during the first week after surgery.

CONDITIONS

Brief Title

Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing general anaesthesia with single-lumen endotracheal tube placement
  • Age 65 years or older, any gender, body mass index (BMI) 18-28 kg/m²
  • Normal mouth opening and head/neck mobility
  • Pre-anaesthesia ASA physical status classification of I or II and Mallampati airway classification of I or II
Not Eligible

You will not qualify if you...

  • Individuals with psychiatric disorders, literacy issues, or communication difficulties unable to cooperate with delirium screening
  • Severe lesions in vital organs such as heart, lungs, brain, liver, or kidneys
  • Undergoing cardiac or neurosurgical procedures during this admission
  • History of alcohol abuse or recent use of sedatives or opioids
  • Hemoglobin less than 100 g/L
  • Participation in any clinical research studies within the past 3 months

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Day of surgery

Participants undergo general anesthesia while preoperative and intraoperative electroencephalogram data are collected using the Neuron-Spectrum-5-1 device.

1 visit (in-person)

Post-operative Follow-up

Duration - 7 days

Participants are monitored for the incidence of postoperative delirium within seven days after surgery.

Daily assessments for up to 7 days post-surgery

Trial Site Locations

Total: 1 location

1

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

Haikou, China

Actively Recruiting

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Research Team

F

Fu Dr.chen

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Processed Multiparameter Electroencephalogram-Guided General Anesthesia Management Can Reduce Postoperative Delirium Following Carotid Endarterectomy: A Randomized Clinical Trial.

Na Xu, Li-Xia Li, Tian-Long Wang...

https://pubmed.ncbi.nlm.nih.gov/34322079

Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients.

César Aldecoa, Gabriella Bettelli, Federico Bilotta...

https://pubmed.ncbi.nlm.nih.gov/37599617