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NCT Number: NCT07323940

Correlation Between Perioperative EEG Variability 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.

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Key information

Conditions

Delirium - Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Haikou, China

Location status: Recruiting

Location contact

Fu Yu

CONTACT

[email protected]

8615475269821

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collect preoperative and intraoperative electroencephalogram data

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fu Dr.chen

CONTACT

[email protected]

8617378224751

Sponsors and collaborators

Lead sponsor

Xin Chen

Other

Collaborators

  • Second Affiliated Hospital of Hainan Medical College

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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