[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535860":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":37,"centralContacts":41,"locations":36,"responsibleParty":46,"collaborators":36,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":36,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":36,"maxAge":58,"enrollmentInfo":59,"targetDuration":36,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":36,"overallStatus":70,"whyStopped":36,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":36},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14,17,21,24,27],{"label":9,"type":10,"description":11,"interventionNames":12},"0.1mg\u002Fkg of ephedrine","ACTIVE_COMPARATOR","If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.\n\nSix single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, 1.2 mg\u002Fkg.\n\nInitially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug.",[13],"Drug: EPHEDrine Hydrochloride 5 mg\u002Fml",{"label":15,"type":10,"description":11,"interventionNames":16},"0.2mg\u002Fkg of ephedrine",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"0.3mg\u002Fkg of ephedrine","If the mean arterial pressure decreases by more than 20% from baseline after induction of anesthesia and infusion of fluids until the start of surgery, a randomized dose of ephedrine will be administered.\n\nSix single doses were evaluated using six cohorts (N=20 per cohort). Subjects received single doses of ephedrine intravenously: 0.1, 0.2, 0.3, 0.5, 1.0, and 1.2 mg\u002Fkg.\n\nInitially, 3 cohorts received the study drug at a given dose, after assessing the safety of ephedrine by the Korean Ministry of Food and Drug Safety, the additional 60 subjects in 3 cohorts received the study drug.",[13],{"label":22,"type":10,"description":19,"interventionNames":23},"0.5mg\u002Fkg of ephedrine",[13],{"label":25,"type":10,"description":19,"interventionNames":26},"1.0mg\u002Fkg of ephedrine",[13],{"label":28,"type":10,"description":19,"interventionNames":29},"1.2mg\u002Fkg of ephedrine",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","EPHEDrine Hydrochloride 5 mg\u002Fml","In the present study, the expected rate of recovery of the internal carotid artery according to the dose of the inotropic agent was similar to that in a previous study in which the fraction maintaining mean arterial pressure within 80% of baseline by dose of inotropic agent was 0.9% for the ephedrine 0.1, 0.6, 0.8, 1. 0, 1.2, and 1.4 doses (mg\u002Fkg) were 9.9%, 21%, 41%, 47%, 65.5%, and 40%, respectively (Br J Anaesth. 2023 May;130(5):603-610), and it was assumed that the rate of internal carotid artery recovery by inotrope dose would be 90% of that result.\n\nThe study will randomize to dose in six cohorts and will include dose group and cohort variables in a logistic regression model to assess the trend between inotropic dose and rate of carotid revascularization after correcting for cohort effects on the outcome variable.",[9,15,18,22,25,28],null,[38],{"name":39,"affiliation":5,"role":40},"Eun-Hee Kim, M.D., Ph.D.","STUDY_CHAIR",[42],{"name":39,"role":43,"phone":44,"phoneExt":36,"email":45},"CONTACT","+82-2-2072-3664","beloveun@snuh.org",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Eun-hee Kim","Clinical associate professor","100535860","phase-4-appropriate-dosage-of-vasopressor-in-neonates-and-infants-100535860",false,"NCT06257316","Appropriate Dosage of Vasopressor in Neonates and Infants","A Study on the Appropriate Dosage of Vasopressors to Maintain Adequate Cerebral Blood Flow During Surgery and Anesthesia in Neonates and Infants","Inclusion Criteria:\n\n* Newborns and infants under 2 years of age undergoing surgery under general anesthesia at Seoul National University Hospital\n\nExclusion Criteria:\n\n* Premature infants with a gestational age of less than 37 weeks\n* Children with a history of brain disease (hydrocephalus, brain tumor, etc.)\n* Patients with a history of hypoxic\u002Fischemic brain injury\n* Children with fused fontanels\n* Children with uncorrected congenital cardiac malformations such as patent ductus arteriosus\n* Patients with hypersensitivity to ephedrine and its components\n* Patients with hypertension\n* Patients with thyrotoxicosis\n* Patients with renal impairment and those taking thyroid medication\n* Glaucoma patients\n* Diabetic patients\n* Patients with prostatic hyperplasia\n* Patients with chromophobe cell tumors\n* Patients taking or within 2 weeks of discontinuing monoamine oxidase inhibitors\n* Patients with ischemic heart disease\n* Patients receiving foxglove preparations\n* Patients with cardiac disease\n* Patients receiving inotropic agents and those with abnormal baseline blood pressure\n* Those who are taking or need to take concomitant contraindicated medications\n* Those who require halogenated anesthetics such as chloroform, cyclopropane, and halothane because concomitant administration may cause ventricular arrhythmias.\n* Those who are expected to require these agents because they may cause arrhythmias or cardiac arrest when coadministered with catecholamines such as epinephrine and isoproterenol.","ALL","2 Years",{"count":60,"type":61},132,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","In this study, the investigators will evaluate cerebral blood flow before and after drug infusion using ultrasound to suggest blood pressure criteria and dosage of ephedrine, a vasopressor, to maintain adequate cerebral blood flow in neonates and infants undergoing surgery and anesthesia.",[67,68,69],"Hypotension","Neonatal Hypotension","Intraoperative Complications","NOT_YET_RECRUITING","2024-02-13",{"date":73,"type":74},"2024-02-15","ACTUAL",{"date":73,"type":61},{"date":77,"type":61},"2028-02-28",{"name":5,"class":6}]