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Recruiting NCT07443072

Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery

Trial Parameters

Condition Cranial Neurosurgery
Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-03-05
Completion 2027-02

Brief Summary

Patients undergoing cranial neurosurgery face a high-risk postoperative period, particularly during emergence from anesthesia and early recovery in the post-anesthesia care unit (PACU). Standard monitoring provides limited insight into brain and autonomic recovery processes. Heart rate variability (HRV) and processed electroencephalography (pEEG) may offer complementary markers of autonomic and cortical function, with potential to improve early detection of complications and guide individualized care.

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

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