[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560652":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":64,"collaborators":32,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":32,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fujian Provincial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Esketamine group","EXPERIMENTAL","During anesthesia induction, 0.2 mg\u002Fkg esketamine was administered intravenously.",[13],"Drug: Esketamine hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.",[19],"Drug: normal saline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Esketamine hydrochloride","During anesthesia induction, a 0.2 mg\u002Fkg esketamine bolus was administered intravenously.",[9],[27],"esketamine hydrochloride injection",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"normal saline","During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Xiaochun Zheng, MD","STUDY_CHAIR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Yusheng Yao, MD&PhD","CONTACT","13559939629","fjslyys@fjmu.edu.cn",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Sisi Chen, MD","15080109541","chensisi49@163.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Fuzhou","Fujian","350001","China","CN",{"type":56,"coordinates":57},"Point",[58,59],119.30611,26.06139,{"lat":59,"lon":58},[62,63],{"name":39,"role":40,"phone":32,"phoneExt":32,"email":32},{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Yao Yusheng","Clinical Professor","100560652","phase-4-effects-of-esketamine-on-postoperative-behavioral-changes-in-children-undergoing-tonsillectomy-andor-adenoidectomy-100560652",false,"NCT06579937","Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and\u002For Adenoidectomy","Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and\u002For Adenoidectomy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* American society of Aneshesiologists physical status I or II;\n* Aged 3-7 years;\n* Scheduled for elective tonsillectomy and (or) adenoidectomy.\n\nExclusion Criteria:\n\n* Parents refusing to allow their children to participate;\n* Intake of sedative or analgesic medication within 48 hours before surgery;\n* Developmental delay;\n* Psychosis;\n* Body mass index \\> 30 kg\u002Fm2;\n* Allergy to study drugs;\n* Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;\n* Any other conditions that precluded study inclusion.","ALL","3 Years","7 Years",{"count":79,"type":80},172,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:\n\nDose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.\n\nParticipants will:\n\nReceive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30",[86],"Behavior Problem",[88,89,90,91,92,93],"esketamine","postoperative negative behavioral change","pediatrics","emergence delirium","tonsillectomy","adenoidectomy","2024-09-27",{"date":96,"type":97},"2024-10-01","ACTUAL",{"date":99,"type":97},"2024-09-02",{"date":101,"type":80},"2025-10-30",{"name":5,"class":6},1]