Heart rate variability and processed EEG to predict recovery after cranial neurosurgery

Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery - A Prospective Observational Study in the Post-Anesthesia Care Unit

This project will test whether measuring heart rate variability and processed EEG during and after brain surgery can help predict early postoperative problems for adults having elective cranial neurosurgery.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (other)
• Locations: 1 site (Milan)
• Trial ID: NCT07443072 on ClinicalTrials.gov

What this trial studies

This is an observational study of adult patients undergoing elective cranial neurosurgery with planned extubation in the PACU. Continuous ECG and processed EEG recordings will be obtained intraoperatively and for at least 60 minutes in the PACU to capture autonomic and cortical recovery patterns. Researchers will analyze heart rate variability and pEEG features to see which patterns correlate with early postoperative complications or delayed recovery. The goal is to identify markers that could help clinicians recognize deterioration earlier and personalize emergence and PACU care.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for elective cranial neurosurgery, planned extubation in the PACU, able to provide informed consent, and able to undergo high-quality intra- and postoperative ECG and EEG monitoring.

Not a fit: Patients with pacemakers or significant cardiac arrhythmias, known severe autonomic neuropathy, preexisting abnormal EEG conditions, or those who require prolonged ventilation or ICU admission immediately after surgery are unlikely to benefit from the monitoring approach.

Why it matters

Potential benefit: If successful, the approach could enable earlier detection of postoperative complications and support more individualized monitoring and management after brain surgery.

How similar studies have performed: Similar uses of HRV and processed EEG in perioperative and critical care settings have shown promising signals for detecting instability but remain preliminary and not yet definitive.

Eligibility criteria

Inclusion Criteria:

* Adult patients (≥18 years) scheduled for elective cranial neurosurgery.
* Planned extubation in the PACU after surgery.
* Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 min expected PACU monitoring).
* Written informed consent signed preoperatively.

Exclusion Criteria:

* Pre-existing severe cardiac arrhythmias (e.g., atrial fibrillation, frequent ectopy) or pacemaker dependence.
* Known severe autonomic neuropathy (e.g., advanced diabetes, Parkinson's disease with autonomic failure).
* Preoperative conditions associated with abnormal EEG (status epilepticus, uncontrolled seizures, sedative/hypnotic overdose).
* Intraoperative or immediate postoperative events necessitating continued mechanical ventilation or ICU admission (e.g., massive bleeding, intraoperative arrest).
* Inability to provide informed consent (e.g., cognitive impairment, language barrier without interpreter).
* Refusal of informed consent

Where this trial is running

Milan

• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (RECRUITING)

Study contacts

• Study coordinator: Andrea Gentile, MD

Conditions: Cranial Neurosurgery, HRV, heart rate variability, EEG, electroencephalography, EEG patterns, EEG signatures, pEEG