Heart rate variability and processed EEG to predict recovery after cranial neurosurgery
Official title: 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
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT07443072 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | March 5, 2026 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07443072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy Recruiting
Study contacts
- Study coordinator: Andrea Gentile, MD
- Email: andrea.gentile@istituto-besta.it
- Phone: + 39 02.2394
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.