[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590121":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":53,"collaborators":33,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":33,"overallStatus":78,"whyStopped":33,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Istinye University","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Saline Infusion","PLACEBO_COMPARATOR","Participants receive 0.9% saline at 30 mL\u002Fhour during surgery.",[13],"Drug: Ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Ketamine Infusion","EXPERIMENTAL","Participants receive ketamine at 0.1 mg\u002Fkg\u002Fhour as intraoperative infusion",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Dexmedetomidine Infusion","Participants receive dexmedetomidine at 0.5 mcg\u002Fkg\u002Fhour as intraoperative infusion",[13],{"label":24,"type":16,"description":25,"interventionNames":26},"Ketamine + Dexmedetomidine","Participants receive a combination of ketamine (0.3 mg\u002Fkg\u002Fhour) and dexmedetomidine (0.5 mcg\u002Fkg\u002Fhour) as intraoperative infusion.",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Ketamine","Ketamine will be administered as an intravenous infusion at 0.1 mg\u002Fkg\u002Fhour during surgery",[20,24,15,9],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"ilke dolgun","CONTACT","+905555485632","ilkeser2004@gmail.com",[41],{"facility":42,"status":33,"city":43,"state":44,"zip":45,"country":46,"countryCode":33,"cosmosGeoPoint":47,"geoPoint":52,"contacts":33},"Istinye Üniversity","Istanbul","Merkez Mahallesi","34250","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],28.94966,41.01384,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":57,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","İlke Dolgun","Assoc. prof","Haseki Training and Research Hospital","100590121","ketamine-and-dexmedetomidine-for-delirium-in-joint-arthroplasty-100590121",false,"NCT06963294","Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty","The Effect of Intraoperative Ketamine and Dexmedetomidine Use on Postoperative Delirium and Cognitive Dysfunction in Patients Undergoing Total Joint Arthroplasty","Inclusion Criteria:\n\n* Scheduled for elective total joint arthroplasty (hip or knee)\n* ASA physical status I-III\n* Age between 18 and 100 years\n* Ability to provide informed consent and comply with cognitive assessments\n\nExclusion Criteria:\n\n* Pre-existing cognitive dysfunction or diagnosed neurodegenerative disease\n* Hearing or language impairment interfering with MMSE\u002FCAM evaluation\n* Known allergy to ketamine or dexmedetomidine\n* Significant cardiac arrhythmia (e.g., supraventricular tachycardia, 2nd or 3rd degree AV block)\n* Renal insufficiency (GFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Severe hepatic dysfunction","ALL","18 Years","100 Years",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"NA","This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of intraoperative ketamine and dexmedetomidine on the incidence of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in patients undergoing total joint arthroplasty. Given the high incidence of neurocognitive complications in elderly patients following major orthopedic surgeries, neuroprotective strategies during anesthesia are of growing interest. Both ketamine and dexmedetomidine have shown potential in reducing neuroinflammation and improving postoperative cognitive outcomes in previous studies.\n\nEighty adult patients (ASA I-III, aged 18-100) scheduled for elective total hip or knee arthroplasty under spinal anesthesia will be randomized into four groups: control (saline infusion), ketamine infusion, dexmedetomidine infusion, and combined ketamine + dexmedetomidine. Cognitive assessments will be performed preoperatively and on postoperative days 2 and 15 using the Mini Mental State Examination (MMSE). Delirium assessments will be conducted using the Confusion Assessment Method (CAM) postoperatively on days 1, 3, and 15.\n\nSecondary outcomes include perioperative levels of cortisol, CRP, and fibrinogen, as well as postoperative pain scores (VAS) and analgesic consumption. The results are expected to clarify whether intraoperative administration of ketamine or dexmedetomidine can reduce the incidence of POD\u002FPOCD and improve postoperative recovery.",[76,77],"Postoperative Delirium","Postoperative Cognitive Dysfunction","NOT_YET_RECRUITING","2025-04-30",{"date":81,"type":82},"2025-05-09","ACTUAL",{"date":84,"type":70},"2026-05-05",{"date":86,"type":70},"2026-07-15",{"name":5,"class":6},1]