[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596507":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":63,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam group","EXPERIMENTAL","A loading dose of remimazolam 0.3 mg\u002FKg was given at anesthesia induction and followed with 1 mg\u002FKg\u002Fh until 10 minutes before the end of surgery. Sevoflurane was used to maintain BIS between 40-60.",[13],"Drug: Remimazolam",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal saline group","PLACEBO_COMPARATOR","An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60",[19],"Drug: Normal Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Remimazolam","After anesthesia induction, a loading investigational drug at a rate of \\[3.6\\*kg\\] ml\u002Fh (lasting for 5 minutes, equivalent to 0.3 mg\u002Fkg of remimazolam), and then adjust the infusion rate to \\[1\\*kg\\] ml\u002Fh (equivalent to 1 mg\u002Fkg of remimazolam). The infusion is expected to stop 10 minutes before the end of the surgery.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline","After anesthesia induction, a loading investigational drug at a rate of \\[3.6\\*kg\\] ml\u002Fh (lasting for 5 minutes, equivalent to 0.3 mg\u002Fkg of normal saline), and then adjust the infusion rate to \\[1\\*kg\\] ml\u002Fh (equivalent to 1 mg\u002Fkg of normal saline). The infusion is expected to stop 10 minutes before the end of the surgery.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dong-liang Mu","CONTACT","+86 010 83575138","mudongliang@bjmu.edu.cn",[38,54],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"NOT_YET_RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":36},"Dong-Liang Mu, Dr.",{"facility":5,"status":55,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"RECRUITING",{"type":46,"coordinates":57},[48,49],{"lat":49,"lon":48},[60],{"name":61,"role":34,"phone":62,"phoneExt":26,"email":36},"Dong-Liang Mu","+8601083575138",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mu Dong Liang","Professor","100596507","phase-4-remimazolam-and-emergence-delirium-in-pediatrics-100596507",false,"NCT07046364","Remimazolam and Emergence Delirium in Pediatrics","The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia","Inclusion Criteria:\n\n* Aged 1 to 6 years old\n* Planned to receive elective neurosurgery under general anesthesia\n* Expected duration of surgery \\> 1 hour\n\nExclusion Criteria:\n\n* Allergy to benzodiazepine\n* Use of other sedatives within 12 hours before surgery such as benzodiazepines, propofol, chloral hydrate, etc.,\n* ASA classification IV or above\n* Unable to complete emergence delirium assessment, such as language, hearing or vision impairment.","ALL","1 Year","6 Years",{"count":78,"type":79},248,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.",[85,86,87,23,88],"Pediatric","Neurosurgery","Sevoflurane Anesthesia","Emergence Delirium",[90,91,92,93,94],"emergence delirium","remimazolam","pediatric","neurosurgery","sevoflurane anesthesia","2025-06-28",{"date":97,"type":98},"2025-07-01","ACTUAL",{"date":100,"type":98},"2025-01-01",{"date":102,"type":79},"2027-01-01",{"name":5,"class":6},2]