[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636883":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Hospital Provincial de Rosario","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"CoreSys-guided anesthesia","EXPERIMENTAL","Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters plus CoreSys monitoring indices (brain activity, stress activity, and response to inflammation). Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. Anesthesia is adjusted according to these parameters.",[13,14,15],"Drug: propofol","Device: CoreSys Monitor","Drug: Remifentanil (Target-Controlled Infusion)",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard anesthesia","ACTIVE_COMPARATOR","Patients receive total intravenous anesthesia guided by standard clinical and hemodynamic parameters. Standard monitoring includes non-invasive blood pressure, electrocardiography, pulse oximetry, and capnography. CoreSys monitoring is performed but not visible to the treating anesthesiologist and does not influence clinical management. Data are recorded by a second investigator.",[13,15],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","propofol","Intravenous administration of propofol using target-controlled infusion (TCI) based on the Marsh pharmacokinetic model for induction and maintenance of general anesthesia.",[9,17],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DEVICE","CoreSys Monitor","A non-invasive monitoring device that integrates electroencephalographic and autonomic signals to assess hypnotic level, nociception, and intraoperative stress indices.",[9],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Remifentanil (Target-Controlled Infusion)","Intravenous administration of remifentanil using target-controlled infusion (TCI) based on the Minto pharmacokinetic model for intraoperative analgesia.",[9,17],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Mariana I Ciancio, MD","CONTACT","+54 9 341 3007811","marianacianciow@gmail.com",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Rosario","Santa Fe Province","S2001SBL","Argentina","AR",{"type":52,"coordinates":53},"Point",[54,55],-60.63932,-32.94682,{"lat":55,"lon":54},[58,59,60],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},{"name":27,"role":40,"phone":27,"phoneExt":27,"email":42},{"name":39,"role":61,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Mariana Ciancio","Anesthesiologist",[66],{"name":67,"class":68},"Coresys Health","INDUSTRY","100636883","coresys-monitoring-for-intraoperative-stress-management-in-abdominal-hysterectomy-100636883",false,"NCT07571473","CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy","CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy: A Randomized Controlled Trial","CORESTRESS","Inclusion Criteria:\n\n* Female patients aged 18-70 years\n* Scheduled elective open abdominal hysterectomy in the morning\n* Written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Significant endocrine\u002Fmetabolic disease\n* Pacemaker or major arrhythmias\n* Contraindication to epidural anesthesia","FEMALE","18 Years","70 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","This randomized controlled trial evaluates whether intraoperative guidance using the CoreSys monitor reduces the surgical stress response in patients undergoing elective open abdominal hysterectomy. Surgical stress involves complex hemodynamic, endocrine, and inflammatory responses that may negatively impact postoperative recovery.\n\nPatients will be randomized to either anesthesia guided by conventional clinical and hemodynamic parameters or anesthesia additionally guided by CoreSys-derived indices of consciousness, nociception, and stress activity. The primary objective is to assess whether CoreSys-guided anesthesia attenuates stress biomarkers, including interleukin-6 (IL-6), cortisol and glycemia.",[88,89,90,91],"Surgical Stress Response","Inflammation","Anesthesia","Perioperative Care",[93,94,95,96,97,98],"CoreSys","Surgical Stress","Total Intravenous Anesthesia","Nociception Monitoring","Anesthesia Depth","IL-6","2026-04-30",{"date":101,"type":102},"2026-05-06","ACTUAL",{"date":104,"type":102},"2025-01-08",{"date":106,"type":82},"2026-05-30",{"name":5,"class":6},1]