Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-01 @ 2:03 PM
Study NCT ID:
NCT04839666
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypersensitivity Reactions to Propofol in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D021181', 'term': 'Egg Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2299}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with a hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.'}], 'secondaryOutcomes': [{'measure': 'Influence of gender on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of gender on hypersensitivity reaction'}, {'measure': 'Influence of ASA on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of ASA on hypersensitivity reaction'}, {'measure': 'Influence of type of procedure on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of type of procedure on hypersensitivity reaction'}, {'measure': 'Influence of age on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of age on hypersensitivity reaction'}, {'measure': 'Influence of weight on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of weight on hypersensitivity reaction'}, {'measure': 'Influence of height on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of height on hypersensitivity reaction'}, {'measure': 'Influence of the experience of the gastroenterologist on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of experience of gastroenterologist on hypersensitivity reaction'}, {'measure': 'Influence of a respiratory comorbitidity on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of respiratory comorbidity on hypersensitivity reaction.'}, {'measure': 'Influence of a neurological comorbidity on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of a neurological comorbidity on hypersensitivity reaction'}, {'measure': 'Influence of reason for investigation on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of the reason for investigation on hypersensitivity reaction'}, {'measure': 'Influence of a respiratory infection on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of a respiratory infection on hypersensitivity reaction.'}, {'measure': 'Influence of GERD on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of GERD on hypersensitivity reaction'}, {'measure': 'Influence of an allergy besides egg or soy on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of another allergy besides egg or soy on hypersensitivity reaction.'}, {'measure': 'Influence of ketamine on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of ketamine on hypersensitivity reaction.'}, {'measure': 'Influence of midazolam on hypersensitivity reaction', 'timeFrame': 'minutes, during surgery', 'description': 'See if there is a link or influence of midazolam on hypersensitivity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypersensitivity', 'Allergy, Egg', 'Soy Allergy']}, 'descriptionModule': {'briefSummary': "The investigators would only include the children who received propofol (Propolipid, Fresenius Kabi, Schelle, Belgium) for sedation, the investigators would exclude the children that didn't receive propofol during the procedure.\n\nThe investigators would analyze the incidence of hypersensitivity reaction to propofol in children allergic to egg, soy or both egg and soy and to compare those with the incidence of hypersensitivity reactions in children without allergy to egg and/or to soy. Those data were retrieved following longitudinal follow-up after the intervention. Allergy tests by skin and radioallergosorbent tests were performed in all children before the gastrointestinal endoscopy under anesthesia took place, but no results were known at the time of the sedation. A patient was defined as allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L).\n\nThe investigators would also investigate the influence of other obtained parameters in the dataset (age, ASA score, weight category, type of investigation, respiratory and neurological comorbidities, respiratory infections, GERD, other allergies) on those results with multivariate analysis.\n\nWe considered that clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations. Depending on the severity of the reaction, necessitating prompt hemodynamic resuscitation with the administration of epinephrine, antihistamines, inhaled beta-agonists or corticosteroids."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children who underwent a surgery in UZ Brussels between the period of 01 January 2010 until 31 August 2016.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnostic gastrointestinal endoscopy\n* monitored anesthesia\n* received propofol during the procedure\n* allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L)\n\nExclusion Criteria:\n\n* Procedure without administration of propofol'}, 'identificationModule': {'nctId': 'NCT04839666', 'briefTitle': 'Hypersensitivity Reactions to Propofol in Children', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy', 'orgStudyIdInfo': {'id': '2021-'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Propofol', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Perioperatively propofol administration', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}