[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504535":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":25,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Novi Sad","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine","EXPERIMENTAL","Evaluate the effects of dexmedetomidine for sedation of patients in the intensive care unit after open heart surgery",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Propofol","ACTIVE_COMPARATOR","Compare the clinical outcomes of the experimental group with the standard of care, i.e. sedation with propofol",[19],"Drug: Propofol",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Upon arrival to the intensive care unit after open heart surgery, the patients will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg\u002Fkg\u002Fh.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Upon arrival to the intensive care unit after open heart surgery, the patients will be sedated with continuous propofol infusion in doses 1-2 mg\u002Fkg\u002Fh.",[15],[30],{"name":31,"affiliation":32,"role":33},"Mihaela Preveden, MD","Institute of Cardiovascular Diseases of Vojvodina","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+381214805702","mihaela.detki@gmail.com",[40],{"facility":32,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Kamenitz","21204","Serbia","RS",{"type":47,"coordinates":48},"Point",[49,50],19.84263,45.22334,{"lat":50,"lon":49},[53],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},{"type":33,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mihaela Preveden","Research Assistant","100504535","phase-3-dexmedetomidinine-in-the-prevention-of-postoperative-delirium-in-the-intensive-care-unit-after-cardiac-surgery-100504535",false,"NCT05849597","Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery","Inclusion Criteria:\n\n* patients undergoing open heart surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair\u002Freplacement, and combined)\n* left ventricular ejection fraction (LVEF) \\>40%.\n\nExclusion Criteria:\n\n* preoperative atrial fibrillation\n* previous history of interventionally treated arrhythmias\n* second and third degree atrioventricular block\n* bradycardia with heart rate ≤50\u002Fmin\n* pacemaker\n* renal or hepatic insufficiency\n* emergency procedures\n* history of serious mental illness, delirium, and severe dementia","ALL","18 Years",{"count":66,"type":67},200,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","This is a prospective, randomized, single blinded, controlled clinical trial designed to compare the clinical effects of sedation with dexmedetomidine versus propofol in patients undergoing cardiac surgery.",[73],"Intensive Care Unit Delirium",[75,76,77,78],"open heart surgery","sedation","dexmedetomidine","postoperative delirium","2024-12-03",{"date":81,"type":82},"2024-12-04","ACTUAL",{"date":84,"type":82},"2022-03-01",{"date":86,"type":67},"2025-06",{"name":5,"class":6},1]