[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591389":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":60,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine + Midazolam 0.4 mg\u002Fkg","EXPERIMENTAL",null,[13],"Drug: Dexmedetomidine + Midazolam 0.4 mg\u002Fkg",{"label":15,"type":10,"description":11,"interventionNames":16},"Dexmedetomidine + Midazolam 0.2 mg\u002Fkg",[17],"Drug: Dexmedetomidine + Midazolam 0.2 mg\u002Fkg",[19,23],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg\u002Fkg combined with intranasal midazolam at a dose of 0.4 mg\u002Fkg, administered 30 minutes before the induction of general anesthesia.",[9],{"type":20,"name":15,"description":24,"armGroupLabels":25,"otherNames":11},"Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg\u002Fkg combined with intranasal midazolam at a dose of 0.2 mg\u002Fkg, administered 30 minutes before the induction of general anesthesia.",[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Ahmed AEH Ellhwany","CONTACT","+201013890313","ahmed.abdalaty2009@gmail.com",[33,49],{"facility":34,"status":11,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Kasr Al-Ainy Hospital, Cairo University","Cairo","11562","Egypt","EG",{"type":40,"coordinates":41},"Point",[42,43],31.24967,30.06263,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":11,"phoneExt":11,"email":11},"Manar M Elkholy, PROF. DR","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":11,"city":51,"state":11,"zip":11,"country":37,"countryCode":38,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Souad Kafafi University Hospital, Misr University for Science and","Giza",{"type":40,"coordinates":53},[54,55],31.20861,30.00944,{"lat":55,"lon":54},[58],{"name":59,"role":48,"phone":11,"phoneExt":11,"email":11},"Haitham A Ali, PROF. DR",{"type":48,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":63,"oldNameTitle":11,"oldOrganization":11},"Ahmed AbdElaty Hamed Ellhwany","Assistant Lecturer","Misr University for Science and Technology","100591389","phase-2-comparing-two-doses-of-midazolam-with-added-dexmedetomidine-for-kids-before-surgery-100591389",false,"NCT06979791","Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery","Comparison Between the Effects of Adding Intranasal Dexmedetomidine to Two Different Doses of Midazolam as a Premedication in Pediatrics Undergoing Elective Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Pediatric patients aged 1 to 8 years\n* Scheduled for elective surgery under general anesthesia\n* Surgery duration \\\u003C 1 hour\n* ASA physical status I or II\n* Parent or legal guardian able to provide informed consent\n\nExclusion Criteria:\n\n* Refusal to participate by parent\u002Fguardian\n* Nasal infections, pathology, or epistaxis\n* Runny nose or upper respiratory tract infection\n* Enlarged adenoids\n* BMI \\> 30\n* Known allergy to dexmedetomidine or midazolam\n* Fever on day of surgery\n* Coagulopathy\n* Scheduled for cardiothoracic or neurosurgical procedures\n* Congenital heart disease\n* Neurological or mental disorders\n* Pre-existing sedation (MOASS \\\u003C 5) on the day of surgery","ALL","1 Year","8 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:\n\nDoes combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?\n\nHow do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?\n\nResearchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg\u002Fkg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg\u002Fkg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.\n\nParticipants will:\n\nReceive intranasal dexmedetomidine (2 mcg\u002Fkg) combined with either 0.4 mg\u002Fkg or 0.2 mg\u002Fkg of intranasal midazolam.\n\nUndergo sedation scoring at 15 and 30 minutes after drug administration.\n\nBe assessed for ease of separation from parents and acceptance of anesthesia mask.\n\nBe monitored for vital signs, recovery times, and any perioperative adverse events.",[82,83],"Preoperative Anxiety Experienced by the Pediatric Patient","Preoperative Anxiety",[85],""pediatric premedication" "dexmedetomidine" "midazolam" "sedation" "mask acceptance"","NOT_YET_RECRUITING","2025-05-16",{"date":89,"type":90},"2025-05-20","ACTUAL",{"date":92,"type":76},"2025-06-01",{"date":94,"type":76},"2025-12",{"name":5,"class":6},2]