Delirium - PostoperativeNCT07323940
Correlation Between Perioperative EEG Variability and Postoperative Delirium Incidence.
An observational study of Delirium - Postoperative, run by Xin Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- Collect preoperative and intraoperative electroencephalogram data
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 12 Dec 2027
- How long will I take part?
- 8 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly surgical patients undergoing general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology,the Second Affiliated Hospital of Hainan Medical University
Haikou
Fu Yu, 8615475269821, yfu8599@gmail.com
About this study
Official title: Correlation Between Multiscale Entropy Analysis of Electroencephalograms 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.
- Conditions
- Delirium - Postoperative
- Being tested
- Collect preoperative and intraoperative electroencephalogram data
- Keywords
- Postoperative delirium, electroencephalogram, Multiscale Entropy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect preoperative and intraoperative electroencephalogram dataDevice
Use Neuron-Spectrum-5-1 to collect preoperative and intraoperative electroencephalogram data.
| Study group | Role | What they receive |
|---|---|---|
| Elderly surgical patients undergoing general anaesthesia. | Not described Receives: Device: Collect preoperative and intraoperative electroencephalogram data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Using the 3D-CAM scale to assess postoperative delirium in surgical patients.
Measured: Within seven days after surgery(Day 0-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start12 Dec 2025
- Primary completion12 Dec 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Xin Chen
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University
- Responsible party
- Sponsor-investigator, Xin Chen, Hainan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323940
- Sponsor's protocol ID
- HUMU2H-EEGAMSE-CN-2025
- Other IDs
- No.823RC592
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34322079Inouye 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 23992774Aldecoa 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Multiscale Entropy Analysis of Electroencephalograms and Postoperative Delirium Incidence.
- ClinicalTrials.gov ID
- NCT07323940
- Acronym / sponsor ID
- HUMU2H-EEGAMSE-CN-2025
- Conditions
- Delirium - Postoperative
- Keywords
- Postoperative delirium, electroencephalogram, Multiscale Entropy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xin ChenUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly surgical patients undergoing general anaesthesia. | – | Device: Collect preoperative and intraoperative electroencephalogram data |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly surgical patients undergoing general anesthesia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect preoperative and intraoperative electroencephalogram dataUse Neuron-Spectrum-5-1 to collect preoperative and intraoperative electroencephalogram data. | Device | Elderly surgical patients undergoing general anaesthesia. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 34322079Xu 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.
- Results publication: PubMed 23992774Inouye 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.
- Results publication: PubMed 37599617Aldecoa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative, run by Xin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu Dr.chen (8617378224751, Dr_chen1699@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Within seven days after surgery(Day 0-7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323940, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.