[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preoperative-sedation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preoperative-sedation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33],"Preoperative Anxiety","Preoperative Sedation","Children","Dexmedetomidine","Esketamine","ED95","ED50","Preoperative Sedation of Children",[26,35,28,29,30,31,32,36],"Preoperative sedation","preoperative sedation of children","RECRUITING","2025-11-24",{"date":40,"type":41},"2025-12-02","ACTUAL",{"date":43,"type":41},"2025-03-01",{"date":45,"type":20},"2025-11-30",{"name":47,"class":48},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100605914","phase-2-the-study-is-being-conducted-to-evaluate-the-efficacy-and-safety-of-dexmedetomidine-hydrochloride-microneedles-for-preoperative-sedation-in-children-100605914","NCT07168720","The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children","Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children","Inclusion Criteria:\n\n* Aged 2 years to 6 years (inclusive ), any genders;\n* Body weight meeting the criteria:\n* Scheduled to undergo general anesthesia for surgery\u002Fprocedure\n* American Society of Anesthesiologists（ASA） I\\~II\n* Provide written informed consent from the legal guardian\n\nExclusion Criteria:\n\n* Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients;\n* Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives;\n* History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases;\n* History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product;\n* History of thoracic, cardiac, or brain surgery;\n* Presence of large areas of skin damage or skin conditions unsuitable for topical patch application on the inner aspects of both forearms or the outer aspects of both thighs;\n* Abnormal liver\u002Fkidney function test values (ALT or AST \\>1.5 times the upper limit of normal \\[ULN\\], or bilirubin \\>1.5 × ULN, or serum creatinine \\>1.5 × ULN);\n* Severe cardiovascular diseases (e.g., fulminant myocarditis, high-grade or third-degree atrioventricular block, sick sinus syndrome, severe arrhythmia, cardiomyopathy, severe pulmonary hypertension, pulmonary atresia, heart failure);\n* Anemia requiring treatment, as judged by the investigator (hemoglobin \\\u003C80 g\u002FL);\n* Use of highly selective α2 agonists or antagonists prior to randomization, where the time since last dose is less than 7 half-lives;\n* Participation in another clinical trial (meaning having received an investigational drug or device) within 3 months prior to screening;\n* Presence of severe psychiatric illness at screening leading to inability or unwillingness to cooperate;\n* Other situations deemed by the investigator as unsuitable for inclusion.","2 Years","6 Years",{"count":59,"type":20},64,[61],"PHASE2","The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children",[27],"2025-09-15",{"date":66,"type":41},"2025-09-19",{"date":68,"type":41},"2025-08-29",{"date":70,"type":20},"2026-04-30",{"name":72,"class":73},"Guangzhou Novaken Pharm Co., Ltd.","INDUSTRY",1]