[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636394":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":66,"collaborators":43,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":43,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":43,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine Group","EXPERIMENTAL","Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg\u002Fkg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Midazolam Group","ACTIVE_COMPARATOR","Participants in this group will receive oral midazolam at a dose of 0.5 mg\u002Fkg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding. This approach ensures consistent administration routes across study groups.",[19],"Drug: Midazolam",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Intranasal dexmedetomidine administered at a dose of 2 mcg\u002Fkg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.",[9],[27],"Precedex",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Midazolam","Oral midazolam administered at a dose of 0.5 mg\u002Fkg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.",[15],[33],"Dormicum",[35],{"name":36,"affiliation":5,"role":37},"Fatma Acil, M.D.","STUDY_DIRECTOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Siyament Cangir, M.D.","CONTACT","+905534411047",null,"siyamentcangir@gmail.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Fatma K Acil, M.D.","+905337225225","acilfatma@gmail.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Siyament Cangir","RECRUITING","Diyarbakır","Outside of the US","21070","Turkey (Türkiye)",{"type":58,"coordinates":59},"Point",[60,61],40.21721,37.91363,{"lat":61,"lon":60},[64,65],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":36,"role":41,"phone":47,"phoneExt":43,"email":48},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Siyament cangir","Principal Investigator","100636394","intranasal-dexmedetomidine-vs-oral-midazolam-for-premedication-in-pediatric-surgery-100636394",false,"NCT07565116","Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery","Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial","Inclusion Criteria:\n\n* Pediatric patients aged 2-10 years\n* ASA physical status I-II\n* Scheduled for elective inguinal or urological surgery under general anesthesia\n* Both male and female patients\n* Written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to dexmedetomidine or midazolam\n* Presence of significant systemic disease or organ dysfunction\n* Cardiac arrhythmia or congenital heart disease\n* Neurological or behavioral disorders, including developmental delay\n* Chronic use of analgesics or other medications that may affect study outcomes\n* Anticipated difficult airway\n* Nasal pathology that may interfere with intranasal drug administration\n* Emergency surgery\n* Inability to obtain written informed consent from parents or legal guardians","ALL","2 Years","10 Years",{"count":81,"type":82},84,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.\n\nPremedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.\n\nIn this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2.\n\nSecondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.",[88,89,90],"Pediatric Anesthesia","Preoperative Anxiety","Emergence Agitation",[88,89,90],"2026-05-11",{"date":94,"type":95},"2026-05-14","ACTUAL",{"date":97,"type":95},"2026-05-05",{"date":99,"type":82},"2026-09-26",{"name":5,"class":6},1]