[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581678":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":66,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":92,"overallStatus":59,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"1-3 years old","EXPERIMENTAL","The sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg\u002Fkg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg\u002Fkg until the number of participants reached 40.",[13,14],"Drug: dexmedetomidine","Drug: Esketamine",{"label":16,"type":10,"description":11,"interventionNames":17},"3-6 years old",[13,14],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","dexmedetomidine","esketamine 0.5mg\u002Fkg intranasally via a nasal dropper, dexmedetomidine 1μg\u002Fkg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg\u002Fkg.",[9,16],null,{"type":20,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Esketamine",[9,16],[29],{"name":30,"affiliation":5,"role":31},"Huacheng Liu","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","18957755138","huachengliu@163.com",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},"Chenrui Zhou","15157910160","zcr934419@163.com",[42,58],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University","NOT_YET_RECRUITING","Wenzhou","Zhejiang","325000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.66682,27.99942,{"lat":54,"lon":53},[57],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},{"facility":43,"status":59,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"RECRUITING",{"type":51,"coordinates":61},[53,54],{"lat":54,"lon":53},[64,65],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},{"type":67,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100581678","phase-4-determination-of-ed50-and-ed95-with-clinical-efficacy-of-intranasal-dexmedetomidine-combined-with-esketamine-for-preoperative-sedation-in-pediatric-general-anesthesia-100581678",false,"NCT06853431","Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia","Inclusion Criteria:\n\n1. ASA physical status classification Grade I or II;\n2. Age 1-6 years old;\n3. Children who need to undergo general anesthesia for elective surgery;\n4. Weight within the normal range;\n5. Signed informed consent form. -\n\nExclusion Criteria:\n\n1. The child's guardian or the child themselves refuses to participate in the study;\n2. Patients with contraindications for sedation\u002Fanesthesia or a history of abnormal recovery from sedation\u002Fanesthesia;\n3. Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;\n4. Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;\n5. Individuals with an upper respiratory tract infection within the past two weeks;\n6. Individuals with other diseases that may cause harm to the subject. -","ALL","12 Months","72 Months",{"count":78,"type":79},80,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \\[6\\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.",[85,86,87,88,26,89,90,91],"Preoperative Anxiety","Preoperative Sedation","Children","Dexmedetomidine","ED95","ED50","Preoperative Sedation of Children",[85,93,87,88,26,89,90,94],"Preoperative sedation","preoperative sedation of children","2025-11-24",{"date":97,"type":98},"2025-12-02","ACTUAL",{"date":100,"type":98},"2025-03-01",{"date":102,"type":79},"2025-11-30",{"name":5,"class":6},2]