[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615963":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":28,"studyPopulation":18,"armGroups":29,"interventions":41,"overallOfficials":51,"centralContacts":55,"locations":62,"responsibleParty":138,"collaborators":140,"id":147,"slug":18,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":18,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":171,"whyStopped":18,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"University Hospital Ostrava","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Effect of BIS monitoring on the incidence of postoperative nausea and vomiting","Effect of BIS monitoring on the incidence of postoperative nausea and vomiting within 24 hours after surgery under general anaesthesia. Vomiting is defined as the expulsion of gastric contents through the oral cavity. Nausea is defined for the purposes of this study using the Baxter Animated Retching Face (BARF) score of 4 or more.","24 hours",[14],{"measure":15,"description":16,"timeFrame":17},"Effect of BIS monitoring on the incidence of emergent delirium","Effect of BIS monitoring on the incidence of emergent delirium (Paediatric Anaesthesia Emergence Delirium (PAED) above 10 and Watcha scale above 3) in the PACU.","1 hour from surgery",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","INVESTIGATOR","Immediately after securing the airway, an electrode will be attached and BIS monitoring will begin. This will be used to control the depth of general anaesthesia throughout the entire surgical procedure, with the aim of achieving BIS values of 40-60.\n\nIntervention group: Following the administration of dexamethasone at the same dos-age as in the control group, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.\n\nControl group: Once access to the vascular system has been secured, dexamethasone will be administered intravenously at a dose of 0.15 mg\u002Fkg body weight, up to a maxi-mum of 5 mg. 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).",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"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.",[35],"Procedure: BIS monitoring",{"label":37,"type":32,"description":38,"interventionNames":39},"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).",[40],"Procedure: Sham BIS monitoring",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":18},"PROCEDURE","BIS monitoring","BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.",[31],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":18},"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.",[37],[52],{"name":53,"affiliation":5,"role":54},"Michal Frelich, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Jiří Hynčica","CONTACT","+42059737","2587","jiri.hyncica@fno.cz",[63,77,94,110,123],{"facility":5,"status":18,"city":64,"state":65,"zip":66,"country":67,"countryCode":18,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Ostrava","Moravian-Silesian Region","708 52","Czechia",{"type":69,"coordinates":70},"Point",[71,72],18.28204,49.83465,{"lat":72,"lon":71},[75,76],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},{"facility":78,"status":18,"city":79,"state":18,"zip":80,"country":67,"countryCode":18,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Frýdek-Místek Hospital","Frýdek-Místek","738 01",{"type":69,"coordinates":82},[83,84],18.35,49.68333,{"lat":84,"lon":83},[87,92],{"name":88,"role":58,"phone":89,"phoneExt":90,"email":91},"Kateřina Kusznírová, MD","+42055841","5111","info@nemfm.cz",{"name":93,"role":54,"phone":18,"phoneExt":18,"email":18},"Kusznírová, MD",{"facility":95,"status":18,"city":96,"state":18,"zip":97,"country":67,"countryCode":18,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Havířov Hospital","Havířov","736 01",{"type":69,"coordinates":99},[100,101],18.43688,49.77984,{"lat":101,"lon":100},[104,109],{"name":105,"role":58,"phone":106,"phoneExt":107,"email":108},"Daniel Kmec, MD","+42059649","1111","sekretariat@nemhav.cz",{"name":105,"role":54,"phone":18,"phoneExt":18,"email":18},{"facility":111,"status":18,"city":64,"state":18,"zip":112,"country":67,"countryCode":18,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Municipal Hospital Ostrava","728 80",{"type":69,"coordinates":114},[71,72],{"lat":72,"lon":71},[117,122],{"name":118,"role":58,"phone":119,"phoneExt":120,"email":121},"Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA","+42059619","2555","martin.formanek@mnof.cz",{"name":118,"role":54,"phone":18,"phoneExt":18,"email":18},{"facility":124,"status":18,"city":125,"state":18,"zip":126,"country":67,"countryCode":18,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Tomáš Baťa Hospital, Zlín","Zlín","762 75",{"type":69,"coordinates":128},[129,130],17.67065,49.22645,{"lat":130,"lon":129},[133,137],{"name":134,"role":58,"phone":135,"phoneExt":107,"email":136},"Klára Nekvindová, MD","+42057755","podatelna@bnzlin.cz",{"name":134,"role":54,"phone":18,"phoneExt":18,"email":18},{"type":139,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[141,142,144,145],{"name":111,"class":6},{"name":95,"class":143},"UNKNOWN",{"name":78,"class":143},{"name":146,"class":6},"Tomas Bata Hospital, Czech Republic","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":158,"type":159},1508,"ESTIMATED","INTERVENTIONAL",[162],"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.",[165],"Tonsil Hypertrophy",[167,168,169,170],"postoperative nausea and vomiting","emergence delirium","children","ENT surgery","NOT_YET_RECRUITING","2025-12-09",{"date":174,"type":175},"2025-12-23","ACTUAL",{"date":177,"type":159},"2026-01-05",{"date":179,"type":159},"2029-01",{"name":5,"class":6},5]