[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615963":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":41,"responsibleParty":117,"collaborators":119,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":25,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":151,"whyStopped":25,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"University Hospital Ostrava","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group - BIS monitoring","EXPERIMENTAL","Following the administration of dexamethasone, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.",[13],"Procedure: BIS monitoring",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group - sham BIS monitoring","A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1).",[18],"Procedure: Sham BIS monitoring",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","BIS monitoring","BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham BIS monitoring","Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.",[15],[31],{"name":32,"affiliation":5,"role":33},"Michal Frelich, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Jiří Hynčica","CONTACT","+42059737","2587","jiri.hyncica@fno.cz",[42,56,73,89,102],{"facility":5,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":25,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Ostrava","Moravian-Silesian Region","708 52","Czechia",{"type":48,"coordinates":49},"Point",[50,51],18.28204,49.83465,{"lat":51,"lon":50},[54,55],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":57,"status":25,"city":58,"state":25,"zip":59,"country":46,"countryCode":25,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Frýdek-Místek Hospital","Frýdek-Místek","738 01",{"type":48,"coordinates":61},[62,63],18.35,49.68333,{"lat":63,"lon":62},[66,71],{"name":67,"role":37,"phone":68,"phoneExt":69,"email":70},"Kateřina Kusznírová, MD","+42055841","5111","info@nemfm.cz",{"name":72,"role":33,"phone":25,"phoneExt":25,"email":25},"Kusznírová, MD",{"facility":74,"status":25,"city":75,"state":25,"zip":76,"country":46,"countryCode":25,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Havířov Hospital","Havířov","736 01",{"type":48,"coordinates":78},[79,80],18.43688,49.77984,{"lat":80,"lon":79},[83,88],{"name":84,"role":37,"phone":85,"phoneExt":86,"email":87},"Daniel Kmec, MD","+42059649","1111","sekretariat@nemhav.cz",{"name":84,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":90,"status":25,"city":43,"state":25,"zip":91,"country":46,"countryCode":25,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Municipal Hospital Ostrava","728 80",{"type":48,"coordinates":93},[50,51],{"lat":51,"lon":50},[96,101],{"name":97,"role":37,"phone":98,"phoneExt":99,"email":100},"Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA","+42059619","2555","martin.formanek@mnof.cz",{"name":97,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":103,"status":25,"city":104,"state":25,"zip":105,"country":46,"countryCode":25,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Tomáš Baťa Hospital, Zlín","Zlín","762 75",{"type":48,"coordinates":107},[108,109],17.67065,49.22645,{"lat":109,"lon":108},[112,116],{"name":113,"role":37,"phone":114,"phoneExt":86,"email":115},"Klára Nekvindová, MD","+42057755","podatelna@bnzlin.cz",{"name":113,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":118,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[120,121,123,124],{"name":90,"class":6},{"name":74,"class":122},"UNKNOWN",{"name":57,"class":122},{"name":125,"class":6},"Tomas Bata Hospital, Czech Republic","100615963","effect-of-the-combination-of-dexamethasone-and-bis-monitoring-on-reducing-postoperative-nausea-and-vomiting-in-children-100615963",false,"NCT07299435","Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children","Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children: a Multicenter Prospective Double-blind Study (BISDEX TRIAL)","BISDEX","Inclusion Criteria:\n\n* children aged 2 to 8 years undergoing endoscopic adenoidectomy\n* parental\u002Fchild consent\n* ASA I-II (American Society of Anaesthesiologists Physical Status)\n* no central nervous system (CNS) or gastrointestinal tract (GIT) disease\n* no corticosteroid medication\n\nExclusion Criteria:\n\n* Parent\u002Fchild disapproval\n* ASA III and above (American Society of Anaesthesiologists Physical Status)\n* central nervous system (CNS) or gastrointestinal tract (GIT) disease\n* chronic corticosteroid therapy","ALL","2 Years","8 Years",{"count":138,"type":139},1508,"ESTIMATED","INTERVENTIONAL",[142],"NA","This study will investigate the impact of combining dexamethasone and bispectral index (BIS) monitoring on the incidence of postoperative nausea and vomiting, emergence delirium and recovery trajectories in children undergoing ear-nose-throat (ENT) surgery.",[145],"Tonsil Hypertrophy",[147,148,149,150],"postoperative nausea and vomiting","emergence delirium","children","ENT surgery","NOT_YET_RECRUITING","2025-12-09",{"date":154,"type":155},"2025-12-23","ACTUAL",{"date":157,"type":139},"2026-01-05",{"date":159,"type":139},"2029-01",{"name":5,"class":6},5]