[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570610":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":7,"responsibleParty":19,"collaborators":7,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":27,"eligibilityCriteria":28,"healthyVolunteers":29,"sex":30,"minAge":31,"maxAge":7,"enrollmentInfo":32,"targetDuration":7,"studyType":35,"phases":7,"briefSummary":36,"conditions":37,"keywords":41,"overallStatus":45,"whyStopped":7,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":7},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",null,[9],{"name":10,"affiliation":5,"role":11},"Christine Eckhardt, MD, PhD","PRINCIPAL_INVESTIGATOR",[13],{"name":14,"role":15,"phone":16,"phoneExt":17,"email":18},"Barbara Sinner, Prof Dr MBA","CONTACT","43 (0) 512 504-0","43 (0) 512 504","barbara.sinner@i-med.ac.at",{"type":20,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100570610","predicting-postoperative-delirium-with-heart-rate-variability-obtained-by-analgesia-nociception-index-100570610",false,"NCT06709482","Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index","Predicting Postoperative Delirium With Heart Rate Variability Obtained by Analgesia Nociception Index - A Prospective Clinical Pilot Study","DANI","Inclusion Criteria:\n\n1. \\> 50 years of age\n2. Scheduled for elective moderate to major risk traumatology or orthopedic surgery (excluding spine surgery) and anticipated duration of general anaesthesia ≥ 60 minutes.\n\nExclusion Criteria:\n\n1. Delirium before surgery.\n2. Patients with emergency surgery\n3. Contraindication to general anesthesia\n4. ASA ≥ 4.\n5. Terminal disease.\n6. h\u002Fo documented dementia, MoCA Score \\\u003C18\n7. h\u002Fo atrial fibrillation\n8. h\u002Fo Parkinson´s disease \u002F Multiple system atrophy \u002F Pure autonomic failure\n9. h\u002Fo autonomic dysfunction (neurogenic autonomic dysfunction)\n10. h\u002Fo stroke\u002Fintracerebral hemorrhage\n11. Cerebral neoplasia\n12. h\u002Fo chronic central nervous disorder (e.g. multiple sclerosis)\n13. Major Depression\n14. Language, vision, or hearing impairments that may compromise delirium or cognitive assessments.\n15. h\u002Fo malignant hyperthermia\n16. h\u002Fo structural muscle disease\n17. h\u002Fo substance abuse\n18. h\u002Fo polyneuropathy\n19. h\u002Fo psychiatric disease\n20. h\u002Fo or current substance use disorder (DSM V)",true,"ALL","50 Years",{"count":33,"type":34},150,"ESTIMATED","OBSERVATIONAL","The aim of this pilot study is to establish a correlation between perioperative heart rate variability (HRV) as an expression of the shift in the balance of the autonomic nervous system and the occurrence of postoperative inflammation and delirium. The main question it aims to answer is: Do patient with increased sympathetic nervous system activity develop postoperative delirium (POD) more often than patients with increased parasympathetic tone?",[38,39,40],"POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","Heart Rate Variability","Biomarkers",[42,43,44],"postoperative delirium","inflammation","heart rate variability","NOT_YET_RECRUITING","2025-03-06",{"date":48,"type":49},"2025-03-07","ACTUAL",{"date":51,"type":34},"2025-03-01",{"date":53,"type":34},"2026-12-01",{"name":5,"class":6}]