[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446269":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":83,"collaborators":43,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":43,"eligibilityCriteria":91,"healthyVolunteers":88,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":43,"studyType":98,"phases":99,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clonidine","EXPERIMENTAL","Participants receive Clonidine solution for injection, 3 microg\u002Fkg, administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Injection is administered from a dilated solution of Clonidine 15 microg\u002FmL (ie., 0.2 mL\u002Fkg).",[13],"Drug: Clonidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive Sodium Chloride isotonic (9mg\u002FmL) solution for injection administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Dosage is administered according to weight: 0.2 mL\u002Fkg.",[19],"Drug: Sodium chloride",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Clonidine injection 3 mcg\u002Fkg once",[9],[26,27],"Catapresan","Catapres",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sodium chloride","Sodium chloride 0.9 % injection 0.2 mL\u002Fkg once",[15],[33],"Normal saline",[35],{"name":36,"affiliation":5,"role":37},"Arash Afshari, PhD","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Bettina Nielsen, PhD","CONTACT","+4535459546",null,"bettina.nygaard.nielsen@regionh.dk",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Anne Louise B Garioud, MD","+4535456243","anne.louise.de.barros.garioud@regionh.dk",[50,69],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Perth Children's Hospital, Department of Anaesthesia and Pain Medicine","RECRUITING","Perth","Nedlands","WA 6009","Australia","AU",{"type":59,"coordinates":60},"Point",[61,62],115.8614,-31.95224,{"lat":62,"lon":61},[65],{"name":66,"role":41,"phone":67,"phoneExt":43,"email":68},"Britta von Ungern-Sternberg, Professor","0061 6456 2222","Britta.Regli-VonUngern@health.wa.gov.au",{"facility":70,"status":52,"city":71,"state":43,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Copenhagen University Hospital, Rigshospitalet","Copenhagen","2100","Denmark","DK",{"type":59,"coordinates":76},[77,78],12.56553,55.67594,{"lat":78,"lon":77},[81,82],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},{"type":37,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Arash Afshari","MD, PhD","100446269","phase-2-the-prevent-agitation-trial-ii---children-1-year-100446269",false,"NCT05091242","The PREVENT AGITATION Trial II - Children ≤1 Year","Inclusion Criteria:\n\n* Paediatric patients (male and female), aged 3- ≤ 12 months\n* Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional\n* The legally acceptable representative for the study participant provides written informed consent\u002Fassent for the trial\n\nExclusion Criteria:\n\n* ASA \\>2\n* Cardiac, neuro and trauma surgery\n* Ex-premature (\\\u003C37 weeks) • Premedication with clonidine\n* Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure\n* Critical illness incl. hemodynamic instability (inotropic drugs needed)\n* Bleeding requiring transfusion prior to scheduled anaesthesia\n* Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid\n* Malignant disease\n* Cardiac disease incl. arrhythmia\n* Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient\n* Mental retardation\n* Neurological disease including symptoms similar to emergence agitation\n* Has or is suspected of having a family or personal history of malignant hyperthermia\n* Has or is suspected of having an allergy to study treatment or its excipients\n* Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data\n* Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)","ALL","3 Months","12 Months",{"count":96,"type":97},336,"ESTIMATED","INTERVENTIONAL",[100,101],"PHASE2","PHASE3","Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment\u002Fprevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.",[104],"Emergence Delirium",[106,9,107,108,109,110,111],"Anesthesia","Sevoflurane","Pharmacokinetics","Postoperative Nausea and Vomiting","Postoperative Pain","Infant","2026-08-11",{"date":114,"type":115},"2026-08-12","ACTUAL",{"date":117,"type":115},"2021-10-25",{"date":119,"type":97},"2028-01-31",{"name":5,"class":6},2]