[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627010":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":18,"responsibleParty":35,"collaborators":7,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":7,"enrollmentInfo":47,"targetDuration":7,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",null,[9,14],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Andrea Gentile, MD","CONTACT","+ 39 02.2394","andrea.gentile@istituto-besta.it",{"name":15,"role":11,"phone":16,"phoneExt":7,"email":17},"Marco Gemma, M.D.","02.2394.","marco.gemma@istituto-besta.it",[19],{"facility":20,"status":21,"city":22,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Fondazione IRCCS Istituto Neurologico Carlo Besta","RECRUITING","Milan","Italy","IT",{"type":26,"coordinates":27},"Point",[28,29],12.59836,42.78235,{"lat":29,"lon":28},[32,33],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},{"name":34,"role":11,"phone":7,"phoneExt":7,"email":17},"Marco Gemma, MD",{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100627010","heart-rate-variability-and-processed-eeg-features-as-predictors-of-postoperative-outcomes-after-cranial-neurosurgery-100627010",false,"NCT07443072","Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes 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","HERO-PACU","Inclusion Criteria:\n\n* Adult patients (≥18 years) scheduled for elective cranial neurosurgery.\n* Planned extubation in the PACU after surgery.\n* Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 min expected PACU monitoring).\n* Written informed consent signed preoperatively.\n\nExclusion Criteria:\n\n* Pre-existing severe cardiac arrhythmias (e.g., atrial fibrillation, frequent ectopy) or pacemaker dependence.\n* Known severe autonomic neuropathy (e.g., advanced diabetes, Parkinson's disease with autonomic failure).\n* Preoperative conditions associated with abnormal EEG (status epilepticus, uncontrolled seizures, sedative\u002Fhypnotic overdose).\n* Intraoperative or immediate postoperative events necessitating continued mechanical ventilation or ICU admission (e.g., massive bleeding, intraoperative arrest).\n* Inability to provide informed consent (e.g., cognitive impairment, language barrier without interpreter).\n* Refusal of informed consent","ALL","18 Years",{"count":48,"type":49},300,"ESTIMATED","OBSERVATIONAL","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.",[53],"Cranial Neurosurgery",[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"HRV","heart rate variability","EEG","electroencephalography","EEG patterns","EEG signatures","pEEG","processed EEG","Neurosurgery","Monitoring","PACU","Post Anesthesia Care Unit","Autonomous Nervous System","Cortical Function","Outcome after Neurosurgery","Post Operative Period","Post Operative Monitoring","Post Operative Outcome","Anesthesia","Emergence","Awakening","Recovery","2026-03-06",{"date":79,"type":80},"2026-03-10","ACTUAL",{"date":82,"type":80},"2026-03-05",{"date":84,"type":49},"2027-02",{"name":5,"class":6},1]