Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT07299435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1508}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of BIS monitoring on the incidence of postoperative nausea and vomiting', 'timeFrame': '24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Effect of BIS monitoring on the incidence of emergent delirium', 'timeFrame': '1 hour from surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative nausea and vomiting', 'emergence delirium', 'children', 'ENT surgery'], 'conditions': ['Tonsil Hypertrophy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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/kg 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 2 to 8 years undergoing endoscopic adenoidectomy\n* parental/child 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/child 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'}, 'identificationModule': {'nctId': 'NCT07299435', 'acronym': 'BISDEX', 'briefTitle': 'Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'FNO-KARIM-BISDEX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group - BIS monitoring', 'description': '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.', 'interventionNames': ['Procedure: BIS monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Control group - sham BIS monitoring', 'description': "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).", 'interventionNames': ['Procedure: Sham BIS monitoring']}], 'interventions': [{'name': 'BIS monitoring', 'type': 'PROCEDURE', 'description': 'BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.', 'armGroupLabels': ['Intervention group - BIS monitoring']}, {'name': 'Sham BIS monitoring', 'type': 'PROCEDURE', 'description': 'Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.', 'armGroupLabels': ['Control group - sham BIS monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '708 52', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'contacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '+42059737', 'phoneExt': '2587'}, {'name': 'Michal Frelich, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '738 01', 'city': 'Frýdek-Místek', 'country': 'Czechia', 'contacts': [{'name': 'Kateřina Kusznírová, MD', 'role': 'CONTACT', 'email': 'info@nemfm.cz', 'phone': '+42055841', 'phoneExt': '5111'}, {'name': 'Kusznírová, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Frýdek-Místek Hospital', 'geoPoint': {'lat': 49.68333, 'lon': 18.35}}, {'zip': '736 01', 'city': 'Havířov', 'country': 'Czechia', 'contacts': [{'name': 'Daniel Kmec, MD', 'role': 'CONTACT', 'email': 'sekretariat@nemhav.cz', 'phone': '+42059649', 'phoneExt': '1111'}, {'name': 'Daniel Kmec, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Havířov Hospital', 'geoPoint': {'lat': 49.77984, 'lon': 18.43688}}, {'zip': '728 80', 'city': 'Ostrava', 'country': 'Czechia', 'contacts': [{'name': 'Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA', 'role': 'CONTACT', 'email': 'martin.formanek@mnof.cz', 'phone': '+42059619', 'phoneExt': '2555'}, {'name': 'Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Municipal Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '762 75', 'city': 'Zlín', 'country': 'Czechia', 'contacts': [{'name': 'Klára Nekvindová, MD', 'role': 'CONTACT', 'email': 'podatelna@bnzlin.cz', 'phone': '+42057755', 'phoneExt': '1111'}, {'name': 'Klára Nekvindová, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tomáš Baťa Hospital, Zlín', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}], 'centralContacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '+42059737', 'phoneExt': '2587'}], 'overallOfficials': [{'name': 'Michal Frelich, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'collaborators': [{'name': 'Municipal Hospital Ostrava', 'class': 'OTHER'}, {'name': 'Havířov Hospital', 'class': 'UNKNOWN'}, {'name': 'Frýdek-Místek Hospital', 'class': 'UNKNOWN'}, {'name': 'Tomas Bata Hospital, Czech Republic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}