[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644876":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Eleveld model-guided dosing","EXPERIMENTAL",null,[13],"Drug: Eleveld model-guided dosing",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard weight-based label dosing","ACTIVE_COMPARATOR",[18],"Drug: Standard weight-based label dosing",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Eleveld model-guided dosing via a validated web-based calculator",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Induction at 9 mg\u002Fkg\u002Fh and maintenance at 1-2 mg\u002Fkg\u002Fh",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Hansol Kim, M.D.","CONTACT","+82-2-2072-2467","hansolfrkr@gmail.com",[34],{"facility":5,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":11,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Seoul","Jongno-gu","03080","South Korea",{"type":40,"coordinates":41},"Point",[42,43],126.9784,37.566,{"lat":43,"lon":42},[46],{"name":47,"role":30,"phone":31,"phoneExt":11,"email":48},"Seokha Yoo","muroki85@snu.ac.kr",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Hansol Kim, MD","Clinical Assistant Professor",[54],{"name":55,"class":56},"Hana Pharm Co., Ltd.","INDUSTRY","100644876","phase-4-efficacy-and-safety-of-eleveld-pkpd-model-based-dosing-during-general-anesthesia-100644876",false,"NCT07675850","Efficacy and Safety of Eleveld PK\u002FPD Model-based Dosing During General Anesthesia","Comparison of Efficacy and Safety Between Eleveld PK\u002FPD Model-based Dosing and Standard Dosing During General Anesthesia","Inclusion Criteria:\n\n* Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation\n\nExclusion Criteria:\n\n* Emergency surgery\n* Surgery requiring evoked potential (EP) monitoring\n* Chronic benzodiazepine users\n* Body Mass Index (BMI) ≥ 35 kg\u002F㎡\n* Chronic kidney disease\n* Hepatic dysfunction or chronic liver disease\n* Contraindication or history of hypersensitivity to remimazolam\n* American Society of Anesthesiologists (ASA) physical status ≥ IV\n* Pregnant women\n* Contraindication or history of hypersensitivity to flumazenil","ALL","19 Years","79 Years",{"count":68,"type":69},68,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic\u002Fpharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.\n\nThe main questions it aims to answer are:\n\nDoes Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?\n\nCan the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?\n\nResearchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.\n\nParticipants will:\n\n* Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen.\n* Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor.\n* Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).",[75,76],"Remimazolam","Pharmacokinetics and Pharmacodynamics",[75,78,79],"general anesthesia","pharmacokinetics and pharmacodynamics","NOT_YET_RECRUITING","2026-06-23",{"date":83,"type":84},"2026-06-30","ACTUAL",{"date":86,"type":69},"2026-07-30",{"date":88,"type":69},"2027-05-31",{"name":5,"class":6},1]