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NCT Number: NCT06894238

Electroencephalogram Predicts Post-operative Delirium

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Sanbo Brain Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

Sub-hairline EEG Monitoring

Diagnostic Test

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

Other names: Delirium Assessment, Clinical Data Collection

Primary outcomes

  1. Incidence of Postoperative Delirium (POD)

    Time frame: Within 7 days post-surgery

    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.

Secondary outcomes

  1. Spectral power of Sub-Hairline EEG theta wave

    Time frame: Within 7 days post-surgery

    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.

  2. Hospital Length of Stay

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

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

  3. Incidence of Postoperative Complications (PPCs)

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

    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.

  4. Analysis of EEG Patterns and Delirium Onset

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

    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.

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

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

    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.

Study contacts

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

Liuhan Wu

CONTACT

[email protected]

010-62856764

Zhonghua Shi, PhD,MD

CONTACT

[email protected]

010-62856764

Sponsors and collaborators

Lead sponsor

Beijing Sanbo Brain Hospital

Other

Registry information

Official study title

Frontal-temporal EEG During Anesthesia Recovery Predicts Postoperative Delirium in Neurosurgery: a Single-center, Prospective, Observational Study

Acronym: EPOD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

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

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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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