Actively Recruiting

Age: 18Years +
All Genders
ID06894238

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

Led by Beijing Sanbo Brain Hospital · Updated on 2025-03-25

137

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether sub-hairline electroencephalography (EEG) during anesthesia recovery can predict postoperative delirium (POD) in adults undergoing elective craniotomy. POD is a common neurological complication after major surgery, linked to longer hospital stays and cognitive issues. This prospective observational study focuses on adult neurosurgical patients admitted to the intensive care unit (ICU) after surgery to understand the relationship between EEG patterns and POD. Participants will have continuous sub-hairline EEG monitoring starting at the end of surgery and continuing through early recovery in the ICU. The EEG will focus on frontal and temporal brain regions, measuring spectral power across various frequency bands, burst suppression ratio, and connectivity metrics. POD will be assessed using validated tools including CAM-ICU, DOSS, and FMSE at four visits within the first seven postoperative days, including specific days 1, 7, and two random days between 2 and 5. Throughout the study, researchers will collect clinical data such as patient demographics, anesthesia management, and vital signs to control for confounding factors. EEG data quality will be ensured with strict protocols and cross-checked with medical records. The primary outcome is the incidence of POD within seven days post-surgery. Secondary outcomes include EEG theta wave power, hospital length of stay, postoperative complications, EEG pattern analysis, and respiratory rhythm coupling. Participation lasts until ICU discharge and about one week post-surgery assessments.

CONDITIONS

Brief Title

Electroencephalogram Predicts Post-operative Delirium

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age ≥ 18 years
  • Planned elective neurosurgical surgery
  • ASA physical status I-II
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Known neurological or psychiatric disorders such as epilepsy or Parkinson's disease
  • Preoperative cognitive impairment with MMSE score less than 24
  • Long-term use of central nervous system drugs like antidepressants or antipsychotics
  • Language barriers
  • History of craniotomy within the last 12 months
  • Inability to place frontal-temporal EEG electrodes due to frontal skin injury, severe agitation, or coronal surgical incision
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Diagnostic Evaluation

Duration - Immediately after surgery through early recovery phase

Participants undergo sub-hairline EEG monitoring starting at the end of surgery and continuing through the early recovery phase in the ICU to assess brain function and predict postoperative delirium.

Continuous monitoring during ICU stay

Post-operative Follow-up

Duration - 7 days post-surgery

Participants are assessed for postoperative delirium using validated screening tools on postoperative days 1, 7, and two additional days randomly selected between days 2 and 5.

4 visits for delirium assessment within 7 days after surgery

Trial Site Locations

Total: 2 locations

1

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100090

Actively Recruiting

2

Sanbo Brain Hospital, Captial Medical Universtiy

Beijing, Beijing Municipality, China, 100093

Actively Recruiting

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Research Team

Z

Zhonghua Shi, PhD,MD

L

Liuhan Wu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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