[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636782":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":50,"locations":61,"responsibleParty":79,"collaborators":82,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":55,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":118,"whyStopped":55,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Nanjing Children's Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal Dexmedetomidine","EXPERIMENTAL","Participants receive intranasal dexmedetomidine 2.0 micrograms\u002Fkg approximately 30 minutes before induction of general anesthesia.",[13],"Drug: Dexmedetomidine",{"label":15,"type":10,"description":16,"interventionNames":17},"Intranasal Esketamine","Participants receive intranasal esketamine 1.0 mg\u002Fkg approximately 30 minutes before induction of general anesthesia.",[18],"Drug: Esketamine",{"label":20,"type":21,"description":22,"interventionNames":23},"Normal Saline Control","PLACEBO_COMPARATOR","Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.",[24],"Drug: Normal Saline",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Dexmedetomidine","Intranasal dexmedetomidine 2.0 micrograms\u002Fkg administered once approximately 30 minutes before induction of general anesthesia.",[9],[32],"Dexmedetomidine Hydrochloride",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Esketamine","Intranasal esketamine 1.0 mg\u002Fkg administered once approximately 30 minutes before induction of general anesthesia.",[15],[38],"Esketamine Hydrochloride",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Normal Saline","Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.",[20],[44],"0.9% Sodium Chloride",[46],{"name":47,"affiliation":48,"role":49},"fei sun, Master's","Children's Hospital of Nanjing Medical University","PRINCIPAL_INVESTIGATOR",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Fei Sun, Master's degree","CONTACT","+86 181 0061 9994",null,"drsunfei89@163.com",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Li Zhang, Doctoral degree","+86 138 1540 6629","drzhangli@njmu.edu.cn",[62],{"facility":48,"status":55,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Nanjing","Jiangsu","210008","China","CN",{"type":69,"coordinates":70},"Point",[71,72],118.77778,32.06167,{"lat":72,"lon":71},[75],{"name":76,"role":53,"phone":77,"phoneExt":55,"email":78},"Medical Ethics Committee of Children's Hospital of Nanjing Med","+86 189 5176 2937","drsunfei@njmu.edu.cn",{"type":49,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Sun Fei","Attending Physician",[83,85,87],{"name":84,"class":6},"Zhongda Hospital",{"name":86,"class":6},"Nanjing First Hospital, Nanjing Medical University",{"name":88,"class":6},"Wuxi Women's & Children's Hospital","100636782","phase-4-intranasal-dexmedetomidine-or-esketamine-for-negative-postoperative-behavioral-changes-in-children-100636782",false,"NCT07570160","Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children","Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery","PEDI-NPOBCs","Inclusion Criteria:\n\n1. Children aged 2 to 12 years.\n2. Scheduled to undergo elective day surgery under general anesthesia.\n3. ASA (American Society of Anesthesiologists) physical status I to III.\n\nExclusion Criteria:\n\n1. Congenital diseases or severe liver or kidney dysfunction.\n2. History of allergic reactions to study drugs.\n3. Neuromuscular diseases, cerebral palsy, epilepsy.\n4. Other psychiatric or neurological disorders.\n5. Body mass index (BMI) ≥ 30 kg\u002Fm².\n6. Severe upper respiratory tract infections prior to surgery.\n7. Use of sedatives or analgesics within 48 hours before surgery.\n8. Exposure to major life stressors within 1 month before surgery (e.g., family separation, death of a parent).\n9. Refusal to participate or failure to obtain consent from the child's legal guardian.","ALL","2 Years","12 Years",{"count":101,"type":102},342,"ESTIMATED","INTERVENTIONAL",[105],"PHASE4","The goal of this clinical trial is to learn whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Negative postoperative behavioral changes may include anxiety, sleep problems, nightmares, irritability, or other unusual behaviors after surgery. This study will also examine whether changes in brain wave patterns during the perioperative period are related to these behavioral changes.\n\nThe main questions this study aims to answer are:\n\nDoes intranasal dexmedetomidine reduce negative postoperative behavioral changes in children after day surgery? Does intranasal esketamine reduce negative postoperative behavioral changes in children after day surgery? Are perioperative electroencephalographic (EEG) features associated with negative postoperative behavioral changes? Researchers will compare intranasal dexmedetomidine, intranasal esketamine, and normal saline to see whether these treatments differ in their effects on postoperative behavior and perioperative EEG features.\n\nParticipants will be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal normal saline about 30 minutes before anesthesia. They will receive routine perioperative monitoring, including EEG monitoring during surgery and recovery. They will also be assessed for sedation, pain, and emergence delirium. Follow-up assessments of postoperative behavioral changes will be completed on postoperative days 3, 7, and 28.",[108],"Behavior Problem",[28,34,110,111,112,113,114,115,116,117],"Intranasal Premedication","Pediatric Day Surgery","Negative Postoperative Behavioral Changes","Emergence Delirium","Perioperative Electroencephalography","General Anesthesia","Children","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-29",{"date":121,"type":122},"2026-05-06","ACTUAL",{"date":124,"type":102},"2026-06-01",{"date":126,"type":102},"2027-11-30",{"name":5,"class":6},1]