Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.

NCT ID: NCT07323940

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-12

Study Completion Date

2026-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Delirium - Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elderly surgical patients undergoing general anaesthesia.

Collect preoperative and intraoperative electroencephalogram data

Intervention Type DEVICE

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

Interventions

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Collect preoperative and intraoperative electroencephalogram data

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

Intervention Type DEVICE

Eligibility Criteria

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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

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Hainan Medical College

UNKNOWN

Sponsor Role collaborator

Xin Chen

OTHER

Sponsor Role lead

Responsible Party

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Xin Chen

Associate Researcher,the Second Affiliated Hospital of Hainan Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Haikou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu Dr.chen

Role: CONTACT

8617378224751

Facility Contacts

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Fu Yu

Role: primary

8615475269821

References

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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.

Reference Type RESULT
PMID: 34322079 (View on PubMed)

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.

Reference Type RESULT
PMID: 23992774 (View on PubMed)

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.

Reference Type RESULT
PMID: 37599617 (View on PubMed)

Other Identifiers

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No.823RC592

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUMU2H-EEGAMSE-CN-2025

Identifier Type: -

Identifier Source: org_study_id

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