Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-06 @ 6:58 AM
Study NCT ID:
NCT04150432
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2019-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Consecutive patients will participate in the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propofol plasma concentration versus simultaneous exhaled concentration', 'timeFrame': '5 hours', 'description': 'repeated blood samples of propofol concentration'}], 'secondaryOutcomes': [{'measure': 'Propofol exhaled correlation versus Bispectral Index value (BIS)', 'timeFrame': '5 hours', 'description': 'repeated blood samples of propofol concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Diseases']}, 'descriptionModule': {'briefSummary': 'Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.', 'detailedDescription': 'The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia.\n\nKey secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective eye surgey\n\nExclusion Criteria:\n\n* known propofol hypersensitivity'}, 'identificationModule': {'nctId': 'NCT04150432', 'briefTitle': 'Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children', 'orgStudyIdInfo': {'id': 'Exhaled propofol Children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'propofol', 'description': 'propofol general anesthesia, exhaled measurement of propofol', 'interventionNames': ['Device: Edmon']}], 'interventions': [{'name': 'Edmon', 'type': 'DEVICE', 'description': 'New device for exhaled propofol concentration measurements', 'armGroupLabels': ['propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Johan Raeder, MD, PhD', 'role': 'CONTACT', 'email': 'johan.rader@medisin.uio.no', 'phone': '004792249669'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Johan Raeder, PhD, MD', 'role': 'CONTACT', 'email': 'johan.rader@medisin.uio.no', 'phone': '004792249669'}], 'overallOfficials': [{'name': 'Kristin Thagaard, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Consultant', 'investigatorFullName': 'Johan C Ræder', 'investigatorAffiliation': 'Oslo University Hospital'}}}}