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
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:
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:
Data Collection and Quality Assurance
To ensure data quality and integrity, the study will implement the following procedures:
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:
Secondary Analysis:
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.
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.
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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.
Exclusion Criteria:
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
Patients who do not develop POD within the seven-day postoperative period.
Diagnostic Test: Sub-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
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
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
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
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
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
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
Plan to share: No
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Beijing Sanbo Brain Hospital