Electroencephalogram Predicts Post-operative Delirium

NCT06894238 | Recruiting DMC

• 2 other identifiers: -BeijingSBHSB-
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neurosurgery; Delirium - Postoperative; Brain Tumor Adult

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)

Outcome Measures

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.

  Within 7 days post-surgery

Secondary Outcomes (5)

• Spectral power of Sub-Hairline EEG theta wave

  Within 7 days post-surgery

• Hospital Length of Stay

  through study completion, an average of 30 days

• Incidence of Postoperative Complications (PPCs)

  through study completion, an average of 1 week

• Analysis of EEG Patterns and Delirium Onset

  through study completion, an average of 1 week

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

  through study completion, an average of 1 week

Study Arms (2)

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

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

Also known as: Delirium Assessment, Clinical Data Collection

Non-POD group; POD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (2)

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, 100090, China

RECRUITING

Sanbo Brain Hospital, Captial Medical Universtiy

Beijing, Beijing Municipality, 100093, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zhonghua Shi, PhD,MD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhonghua Shi, PhD,MD

CONTACT

010-62856764; z.shi@mail.ccmu.edu.cn

Liuhan Wu

CONTACT

010-62856764; wlh920585@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Dept. of ICU

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)