[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556475":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":37,"overallOfficials":13,"centralContacts":13,"locations":49,"responsibleParty":69,"collaborators":13,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":13,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":13,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":13,"overallStatus":52,"whyStopped":13,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Kemerovo State Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Biomarkers","monitoring the concentration of markers of brain damage at several control points","16 hours after operation",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":19,"maskingDescription":13,"whoMasked":20},"SINGLE",[21],"PARTICIPANT","The study will examine the safety and effectiveness for neuroprotection of subanesthetic doses of ketamine in the postoperative period in children undergoing operations to correct septal congenital heart defects using cardiopulmonary bypass.",[24,29,32],{"label":25,"type":26,"description":13,"interventionNames":27},"Ketamine 1","EXPERIMENTAL",[28],"Drug: Ketamine Hcl 50Mg\u002FMl Inj",{"label":30,"type":26,"description":13,"interventionNames":31},"Ketamine 3",[28],{"label":33,"type":34,"description":13,"interventionNames":35},"Control","PLACEBO_COMPARATOR",[36],"Other: Control",[38,43,46],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"DRUG","Ketamine Hcl 50Mg\u002FMl Inj","ketamine infusion at a dose of 0.1 mg\u002Fkg\u002Fhour for 16 hours",[25],{"type":39,"name":40,"description":44,"armGroupLabels":45,"otherNames":13},"ketamine infusion at a dose of 0.3 mg\u002Fkg\u002Fhour for 16 hours",[30],{"type":6,"name":33,"description":47,"armGroupLabels":48,"otherNames":13},"Without ketamine",[33],[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Artem Ivkin","RECRUITING","Kemerovo","Please Select","650066","Russia","RU",{"type":59,"coordinates":60},"Point",[61,62],86.10435,55.35417,{"lat":62,"lon":61},[65],{"name":51,"role":66,"phone":67,"phoneExt":13,"email":68},"CONTACT","+79030701880","ivkiaa@kemcardio.ru",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Evgeny Grigoryev","Head of the Department of Anesthesiology","100556475","ketamine-infusion-as-a-method-of-cerebral-protection-in-children-100556475",false,"NCT06525584","Ketamine Infusion as a Method of Cerebral Protection in Children","Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects","Inclusion Criteria:\n\n* age from 1 to 60 months\n* body weight from 3.5 to 20 kg\n* planned surgical intervention to correct a congenital heart defect (atrial or ventricular septal defect) with CPBё\n* the presence of informed consent for participation in the study signed by the child's legal representative\n\nExclusion Criteria:\n\n* lack of informed consent of the patient and parents to participate in the study,\n* emergency and urgent surgical interventions;\n* the presence of clinically significant anemia;\n* hypo-thermic during operation, episodes of desaturation in the perioperative period;\n* the presence of another congenital heart diseases besides the atrial or ventricular septal defect, as well as their combination;\n* a history of central nervous system diseases;\n* an installed pacemaker;\n* hemodynamic instability requiring preoperative pharmacological and\u002For mechanical support;\n* any episodes of cerebrovascular accidents in the history or periop-erative period;\n* the presence of a patient with severe concomitant diseases that worsen mental and somatic conditio;\n* acute infection and exacerbation of chronic infection in the perioperative period;\n* concomitant autoimmune diseases;\n* the presence of malignant neoplasms;\n* surgical complications in the postoperative period.","ALL","1 Month","5 Years",{"count":84,"type":85},196,"ESTIMATED","INTERVENTIONAL",[88],"NA","The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.",[91],"Brain Injuries","2026-08-13",{"date":94,"type":95},"2026-08-17","ACTUAL",{"date":97,"type":95},"2023-11-05",{"date":99,"type":85},"2028-12-30",{"name":5,"class":6},1]