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RecruitingNCT06894238EPODUpdated Mar 25, 2025

Electroencephalogram Predicts Post-operative Delirium

An observational study in Neurosurgery, Delirium - Postoperative and Brain Tumor Adult, sponsored by Beijing Sanbo Brain Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Beijing Sanbo Brain Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
137
Ages
18 Years and older
Sex
All
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Study summary

The goal of this observational study is to investigate the predictive value of sub-hairline electroencephalography (EEG) during anesthesia recovery for postoperative delirium (POD). The main question to be answered is:

  • Can sub-hairline EEG measured during anesthesia recovery serve as a reliable predictor of POD? Adult patients undergoing elective craniotomy and admitted to the ICU will be enrolled. Sub-hairline EEG will be monitored until ICU discharge.
Read the detailed description

Postoperative delirium (POD) is common neurological complication following major surgery, particularly in neurosurgical patients with the incidence ranges from 5% to 37%, depending on the diagnostic criteria and patient subgroups. POD has been associated with increased morbidity, prolonged hospitalisation, long-term cognitive impairment, and higher healthcare costs. Despite its clinical significance, early identification of patients at risk for POD remains a challenge. Electroencephalography (EEG) has been extensively utilised for monitoring brain function in anaesthesia and critical care settings. However, the feasibility and predictive value of sub-hairline EEG during anaesthesia recovery for POD remain largely unexplored.

This prospective observational study aims to assess whether sub-hairline EEG parameters recorded during the immediate anaesthesia recovery phase can serve as reliable predictors of POD in adult patients undergoing elective craniotomy. The study will include patients scheduled for elective craniotomy who are admitted to the intensive care unit (ICU) postoperatively.

Study Design and Procedures

Sub-hairline EEG monitoring will commence at the end of surgery and continue throughout the early recovery phase in the ICU. EEG signals will be continuously recorded using a standardized EEG montage, focusing on frontal and temporal regions. The EEG-derived parameters of interest include:

  • Spectral power across different frequency bands (delta, theta, alpha, beta)
  • Burst suppression ratio
  • Functional connectivity metrics (coherence, phase-amplitude coupling) POD will be assessed using validated screening tools, including the Confusion Assessment Method for the ICU (CAM-ICU), the Delirium Observation Screening Scale (DOSS), and the Fluctuating Mental Status Evaluation (FMSE) within seven days postoperatively. Assessments will be conducted after extubation and between 10:00 AM and 4:00 PM within the first seven postoperative days. A total of four visits will be performed: on postoperative day 1, postoperative day 7, and two randomly selected days between postoperative days 2 and 5.

Data Collection and Quality Assurance

To ensure data quality and integrity, the study will implement the following procedures:

  • Standardized EEG Acquisition and Processing: EEG signals will be collected using a predefined protocol with strict artifact rejection criteria.
  • Clinical Data Recording: Patient demographics, perioperative anesthetic management, hemodynamic stability, postoperative analgesia, respiratory function, and ECG parameters will be recorded to assess potential confounding factors.
  • Source Data Verification: EEG recordings and clinical data will be cross-checked with electronic medical records for accuracy and completeness.
  • Quality Control Measures: Data entry will undergo automated range and consistency checks to minimize errors. Missing or inconsistent data will be flagged and reviewed.

Sample Size and Statistical Analysis Plan A sample size calculation will be conducted to ensure adequate power to detect significant associations between EEG parameters and POD incidence. Based on our past studies, the incidence of POD is 30% after neurosurgery in our hospital. According to the literature search results and related studies, the area under the curve was 0.73, the two-sided test error was 0.05, the statistical power was 0.9, and the 10% dropout rate was considered. Eventually, we plan to enroll 137 participants for elective neurosurgery.

Primary Analysis:

  • The association between EEG parameters during anesthesia recovery and POD will be evaluated using multivariable logistic regression, adjusting for potential confounders.
  • Time-series EEG changes will be analyzed using repeated-measures ANOVA to track EEG dynamics over time.

Secondary Analysis:

  • EEG biomarkers predictive of POD severity will be identified using machine learning approaches, such as decision trees and support vector machines.
  • Subgroup analysis will assess differences based on age, baseline cognitive function, and surgical duration.

Expected Impact By leveraging non-invasive sub-hairline EEG monitoring, this study aims to provide insights into the neurophysiological mechanisms underlying POD and identify early EEG biomarkers for risk stratification. If successful, this research could contribute to the development of real-time EEG-based monitoring tools for early POD detection and prevention, ultimately improving postoperative outcomes in neurosurgical patients.

02

Conditions studied

  • Neurosurgery
  • Delirium - Postoperative
  • Brain Tumor Adult

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Keywords

  • Postoperative delirium
  • electroencephalography
  • neurosurgical patients
  • Sub-hairline EEG
  • Confusion Assessment Method for ICU (CAM-ICU)
  • Delirium Observation Screening Scale (DOSS)
  • Fluctuating Mental Status Evaluation (FMSE)
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 137 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Beijing Sanbo Brain Hospital is the lead sponsor of 17 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will recruit participants from patients scheduled for elective neurosurgical procedures at Sanbo Brain Hospital, Capital Medical Universtiy in Beijing, China. The population will consist of adult patients aged ≥18 years who are classified as ASA physical status I-II, indicating generally healthy individuals or those with mild systemic disease. Participants will be identified through pre-surgical assessments and referred by their attending neurosurgeons for enrollment in the study. This cohort will be selected from those undergoing elective craniotomy. Eligible participants will be consented prior to surgery, and sub-hairline EEG monitoring will be initiated during the early anesthesia recovery phase in the ICU.

Inclusion criteria

  • Age ≥ 18 years
  • Planned elective neurosurgical surgery
  • ASA physical status I-II
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Known neurological or psychiatric disorders (e.g., epilepsy, Parkinson's disease)
  • Preoperative cognitive impairment (MMSE score \< 24)
  • Long-term use of central nervous system drugs (e.g., antidepressants, antipsychotics)
  • Language barriers
  • History of craniotomy within the last 12 months
  • Inability to place frontal-temporal electrodes due to conditions such as frontal skin injury, severe agitation, or a coronal incision for surgery
  • Pregnant or breastfeeding women
05

Study design

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

Groups and cohorts

  • POD group

    Patients who develop POD within seven days after surgery, as assessed using validated screening tools (CAM-ICU, DOSS, FMSE)

    Diagnostic Test: Sub-hairline EEG Monitoring

  • Non-POD group

    Patients who do not develop POD within the seven-day postoperative period.

    Diagnostic Test: Sub-hairline EEG Monitoring

Interventions

  • Diagnostic testSub-hairline EEG Monitoring

    Participants will receive standard postoperative care as per institutional protocols, including neuromonitoring, delirium screening, and ICU management. The study will not alter or assign any treatments but will analyze the association between sub-hairline EEG parameters and postoperative delirium (POD) outcomes

    Also known as: Delirium Assessment, Clinical Data Collection

06

What researchers measure

Primary outcomes

  1. Incidence of Postoperative Delirium (POD)

    The primary outcome of this study is to assess whether sub-hairline EEG parameters recorded during anesthesia recovery can reliably predict the incidence of postoperative delirium (POD) within the first 7 days following elective craniotomy.

    Time frame: Within 7 days post-surgery

Secondary outcomes

  1. Spectral power of Sub-Hairline EEG theta wave

    To evaluate whether changes in sub-hairline EEG parameters (e.g., spectral power, burst suppression ratio, and connectivity metrics) during the early postoperative period are associated with the onset and severity of POD.

    Time frame: Within 7 days post-surgery

  2. Hospital Length of Stay

    To investigate if the use of sub-hairline EEG during anesthesia recovery correlates with the length of ICU and total hospital stay.

    Time frame: through study completion, an average of 30 days

  3. Incidence of Postoperative Complications (PPCs)

    To evaluate the incidence of postoperative complications, including pneumonia, atelectasis, brain ischemia, edema, and haemorrhage, and whether these are correlated with sub-hairline EEG parameters.

    Time frame: through study completion, an average of 1 week

  4. Analysis of EEG Patterns and Delirium Onset

    To explore any correlation between specific sub-hairline EEG patterns (e.g., burst suppression ratio, alpha or theta waves) and the early onset of delirium.

    Time frame: through study completion, an average of 1 week

  5. Phase-Locking Value between sub-Hairline EEG oscillations and respiratory rhythm

    This secondary outcome measure aims to investigate the correlation between sub-hairline EEG parameters and other physiological signals, including electrocardiogram (ECG) and respiratory parameters, to determine their potential predictive value for POD. This study will explore whether these signals show significant interactions or patterns that could help predict the onset of POD and its severity.

    Time frame: through study completion, an average of 1 week

07

Study locations

2 of 2 sites recruiting
  • Beijing Sanbo Brain Hospital, Capital Medical University
    Beijing, Beijing 100090, China
    Recruiting
  • Sanbo Brain Hospital, Captial Medical Universtiy
    Beijing, Beijing 100093, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06894238
Lead sponsor
Beijing Sanbo Brain Hospital
Responsible party
Zhonghua Shi, MD, PhD (Chief Physician, Dept. of ICU, Capital Medical University) — Principal investigator
First posted
Mar 25, 2025
Start date
Mar 1, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Mar 25, 2025

Study contacts

Zhonghua Shi, PhD,MD
Contact
z.shi@mail.ccmu.edu.cn
010-62856764
Liuhan Wu
Contact
wlh920585@163.com
010-62856764
Zhonghua Shi, PhD,MD
principal investigator · Capital Medical University

Oversight

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

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