[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384702":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":151,"collaborators":153,"id":176,"slug":18,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":184,"maxAge":18,"enrollmentInfo":185,"targetDuration":18,"studyType":188,"phases":189,"briefSummary":191,"conditions":192,"keywords":18,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine Hydrochloride Group","ACTIVE_COMPARATOR","Patients will receive a loading dose of 1.2 μg\u002Fkg dexmedetomidine prior to transfer to CVICU over 20-60 min immediately postoperative, followed by continuous infusion of 0.3 μg\u002Fkg\u002Fh for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.",[13],"Drug: Dexmedetomidine Hydrochloride Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Group","NO_INTERVENTION","Standard sedation protocols will be followed at the discretion of the attending physician.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1.2 ug\u002Fkg over approximately 20-60 minutes. This will be followed by an infusion at 0.3 ug\u002Fkg\u002Fh in CVICU for up to 12 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.",[9],[25],"Dexmedetomidine Hydrochloride",[27],{"name":28,"affiliation":5,"role":29},"Stephen Choi, MD,MSc,FRCPC","PRINCIPAL_INVESTIGATOR",[31,36],{"name":28,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","416-480-6100","1711","stephen.choi@sunnybrook.ca",{"name":37,"role":32,"phone":33,"phoneExt":38,"email":39},"Lilia Kaustov, PhD","89607","lilia.kaustov@sunnybrook.ca",[41,54,67,77,106,119,125,141],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":18},"Royal Columbian Hospital","ACTIVE_NOT_RECRUITING","Vancouver","British Columbia","V3L 0A2","Canada",{"type":49,"coordinates":50},"Point",[51,52],-123.11934,49.24966,{"lat":52,"lon":51},{"facility":55,"status":56,"city":44,"state":45,"zip":57,"country":47,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"St. Paul's Hospital","RECRUITING","V6Z 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MD,FRCPC,PhD",{"name":92,"role":93,"phone":18,"phoneExt":18,"email":18},"Angela Jerath, MD,FRCPC","SUB_INVESTIGATOR",{"name":95,"role":93,"phone":18,"phoneExt":18,"email":18},"George Djaiani, MD,FRCPC",{"name":97,"role":93,"phone":18,"phoneExt":18,"email":18},"Philip Jones, MD,FRCPC",{"name":99,"role":93,"phone":18,"phoneExt":18,"email":18},"Summer Syed, MD,FRCPC,MSc",{"name":101,"role":93,"phone":18,"phoneExt":18,"email":18},"David Mazer, MD,FRCPC,PhD",{"name":103,"role":93,"phone":18,"phoneExt":18,"email":18},"Tarit Saha, MD,FRCPC",{"name":105,"role":93,"phone":18,"phoneExt":18,"email":18},"Beverley A Orser, MD,PhD,FRCPC",{"facility":107,"status":108,"city":78,"state":70,"zip":109,"country":47,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"St. Michael's Hospital","NOT_YET_RECRUITING","M5B 1W8",{"type":49,"coordinates":111},[82,83],{"lat":83,"lon":82},[114,117],{"name":115,"role":32,"phone":18,"phoneExt":18,"email":116},"Sanjay Yagnik","Sanjay.Yagnik@unityhealth.to",{"name":118,"role":29,"phone":18,"phoneExt":18,"email":18},"David Mazer",{"facility":120,"status":43,"city":78,"state":70,"zip":121,"country":47,"cosmosGeoPoint":122,"geoPoint":124,"contacts":18},"Toronto General Hospital","M5G 2C4",{"type":49,"coordinates":123},[82,83],{"lat":83,"lon":82},{"facility":126,"status":56,"city":127,"state":128,"zip":129,"country":47,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Laval University","Québec","Quebec","G1V 0A6",{"type":49,"coordinates":131},[132,133],-71.21454,46.81228,{"lat":133,"lon":132},[136,139],{"name":137,"role":32,"phone":18,"phoneExt":18,"email":138},"Francois Laforge","francois.laforge.1@ulaval.ca",{"name":140,"role":29,"phone":18,"phoneExt":18,"email":18},"Etienne Couture",{"facility":142,"status":43,"city":143,"state":144,"zip":145,"country":47,"cosmosGeoPoint":146,"geoPoint":150,"contacts":18},"University of Saskatchewan","Saskatoon","Saskatchewan","S7N 0W8",{"type":49,"coordinates":147},[148,149],-106.66892,52.13238,{"lat":149,"lon":148},{"type":152,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[154,156,158,160,163,165,167,169,171,172,174],{"name":155,"class":6},"London Health Sciences Centre",{"name":157,"class":6},"University Health Network, Toronto",{"name":159,"class":6},"McMaster University",{"name":161,"class":162},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":164,"class":6},"The Dana Foundation",{"name":166,"class":6},"Brain Canada",{"name":168,"class":6},"Alzheimer's Association",{"name":170,"class":6},"Hamilton Health Sciences Corporation",{"name":142,"class":6},{"name":173,"class":6},"Fraser Health",{"name":175,"class":6},"Providence Health & Services","100384702",false,"NCT04289142","Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients","Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial","CODEX","Inclusion Criteria:\n\n* Planned CABG (+\u002F- valve, including off-pump) or valve replacement via sternotomy\u002Fthoracotomy, with initial recovery in the Cardiovascular Intensive Care Unit (CVICU)\n* Age ≥60\n\nExclusion Criteria:\n\n* Lack of patient consent\n* Pre-operative major cognitive dysfunction (CogState Brief Battery score \\\u003C 80) at screening\n* Aortic arch replacement\u002Fre-implantation (surgery requiring hypothermic circulatory arrest, e.g. Bentall procedure)\n* Allergy\u002Fcontraindication to dexmedetomidine (untreated 2nd degree type 2 or 3rd degree heart block (pacemaker), cirrhosis, HR \\\u003C 50 , grade 4 LV, renal failure or on renal replacement therapy)\n* Unlikely to comply with study assessments (e.g. no fixed address, cannot complete cognitive tests at the 3, 6, and 12 month time points)","ALL","60 Years",{"count":186,"type":187},2400,"ESTIMATED","INTERVENTIONAL",[190],"PHASE4","Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.",[193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209],"Delirium","Cognitive Dysfunction","Cognition Disorder","Neurocognitive Disorders","Mental Disorders","Confusion","Neurobehavioral Manifestations","Neurologic Manifestations","Nervous System Diseases","Signs and Symptoms","Dexmedetomidine","Hypnotics and Sedatives","Central Nervous System Depressants","Physiological Effects of Drugs","Analgesics, Non-Narcotic","Analgesics","Molecular Mechanisms of Pharmacological Action","2025-11-27",{"date":212,"type":213},"2025-12-01","ACTUAL",{"date":215,"type":213},"2019-12-01",{"date":217,"type":187},"2029-03",{"name":5,"class":6},8]