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

Recruitingn/aAges 18 Years - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT07443072 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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