[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643437":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":89,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Erzurum City Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative Oral Midazolam","EXPERIMENTAL","Participants in this group will receive oral midazolam at a dose of 0.5 mg\u002Fkg, administered 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration and improve tolerance.",[13],"Drug: Midazolam (Oral)",{"label":15,"type":10,"description":16,"interventionNames":17},"Intraoperative Intravenous Midazolam","Participants in this group will receive intravenous midazolam at a dose of 0.05-0.1 mg\u002Fkg during anesthesia induction.",[18],"Drug: Midazolam (Intravenous)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Midazolam (Oral)","Oral midazolam will be administered at a dose of 0.5 mg\u002Fkg, 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Midazolam (Intravenous)","Intravenous midazolam will be administered at a dose of 0.05-0.1 mg\u002Fkg during anesthesia induction.",[15],[31],{"name":32,"affiliation":5,"role":33},"Mehmet Sercan Orbak, MD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+ 90 (506) 288 35 34","sercanorbak@gmail.com",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Ahmet Ergün, MD","draergn@gmail.com",[43],{"facility":5,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":25,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Erzurum","Yakutiye","25240","Turkey (Türkiye)",{"type":49,"coordinates":50},"Point",[51,52],41.27694,39.90861,{"lat":52,"lon":51},[55],{"name":40,"role":56,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":33,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mehmet Sercan Orbak","Anesthesiology Specialist (MD), Principal Investigator","100643437","timing-of-midazolam-n-children-undergoing-adenotonsillectomy-effects-on-stress-cortisol-and-recovery-100643437",false,"NCT07622641","Timing Of Midazolam İn Children Undergoing Adenotonsillectomy: Effects On Stress, Cortisol, And Recovery","Optimization of Midazolam Administration Timing in Pediatric Adenotonsillectomy: Effects on Cortisol Response, Behavioral Stress, and Recovery Quality","Timing-Midazol","Inclusion Criteria:\n\n* Children aged 3-10 years,\n* Scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy,\n* American Society of Anesthesiologists (ASA) physical status I-II,\n* Written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Children younger than 3 years or older than 10 years,\n* American Society of Anesthesiologists (ASA) physical status greater than II,\n* Known allergy to apple or apple-derived products,\n* Known allergy or hypersensitivity to benzodiazepines,\n* Presence of developmental delay,\n* History of neuropsychiatric disorders,\n* Current or recent use of corticosteroids,\n* Expected or actual surgical duration longer than 90 minutes,\n* Refusal of participation by parents or legal guardians","ALL","3 Years","10 Years",{"count":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study is a prospective, randomized, controlled clinical trial designed to evaluate the optimal timing of midazolam administration in children undergoing adenotonsillectomy. The study will be conducted at the Departments of Otorhinolaryngology and Anesthesiology of Erzurum City Hospital.\n\nMidazolam is commonly used in pediatric patients to reduce anxiety and improve perioperative comfort. However, the optimal timing of its administration (before surgery or during anesthesia induction) remains unclear. This study aims to compare the effects of preoperative oral midazolam and intraoperative intravenous midazolam on stress response, behavioral outcomes, and recovery quality.\n\nParticipants will be randomly assigned to one of two groups. In Group A, children will receive oral midazolam (0.5 mg\u002Fkg) 30 minutes before surgery. In Group B, children will receive intravenous midazolam (0.05-0.1 mg\u002Fkg) during anesthesia induction.\n\nThe primary outcome of the study is the change in serum cortisol levels, which reflects the physiological stress response. Blood samples will be collected twice: once 10 minutes after anesthesia induction and once 15 minutes after surgery in the post-anesthesia care unit.\n\nIn addition to cortisol levels, the study will assess preoperative anxiety using an observational anxiety scale, postoperative pain using a behavioral pain scoring system, and parental satisfaction using a standardized questionnaire. These measures aim to provide a comprehensive evaluation of the child's perioperative experience.\n\nThe findings of this study may help determine the most effective timing of midazolam administration to reduce stress, improve recovery, and enhance overall patient and family satisfaction in pediatric surgical care.",[79,80,81,82],"Adenotonsillectomy","Preoperative Anxiety","Surgical Stress Response","Postoperative Pain",[84,85,79,86,80,87,82,88],"Midazolam","Pediatric Anesthesia","Premedication Timing","Cortisol Response","Recovery Quality","NOT_YET_RECRUITING","2026-06-07",{"date":92,"type":93},"2026-06-10","ACTUAL",{"date":95,"type":73},"2026-08-01",{"date":97,"type":73},"2027-09-01",{"name":5,"class":6},1]