Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04771702
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expired Propofol in Low Back Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The intervention is to have patients in 20 min stable anaesthesia before start of surgery in order to validate the use of exhaled propofol versus pharmakokinetic modelling and measured plasma concentration'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exhaled air versus plasma concentration', 'timeFrame': 'per-operative'}], 'secondaryOutcomes': [{'measure': 'EEG recording', 'timeFrame': 'per-operative', 'description': 'EEG will be recorded and compared with plasma propofol, exhaled propofol and BIS'}, {'measure': 'Exhaled propofol 2', 'timeFrame': 'per-operative', 'description': 'Exhaled propofol versus dose given, estimated plasma concentration, estimated effect site concentration'}, {'measure': 'Nociceptive stimulation', 'timeFrame': 'per-operative', 'description': 'Skin conductance versus plasma and exhaled propofol concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air.\n\nThe study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.', 'detailedDescription': 'Elective low-back surgery patients will be induced for general intubation anesthesia with propofol and remifentanil.\n\nAfter induction a 20 min period of stable propofol infusion only will be established before start of surgery. The patients will be monitored for exhaled propofol, plasma propofol (blood samples), continous frontal EEG, Bispectral Index (BIS), skin conductance, estimated (computer based) concentrations of plasma and effect site propofol, and skin conductance.\n\nAfter start of surgery (with ongoing propofol and restart of remifentanil TCI) the monitoring will continue in order to explore these relationships further.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective patients scheduled for low-back surgery\n* BMI between 20 -32 kg/m2\n* ASA I-II\n* Written informed concent\n\nExclusion Criteria:\n\n* Contraindication to propofol TCI\n* Use of psychopharmaco or neurologic disease\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT04771702', 'briefTitle': 'Expired Propofol in Low Back Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Propofol Measurement in Expiration Air and Monitoring of EEG and Pain in Patients Undergoing Low Back Surgery', 'orgStudyIdInfo': {'id': 'Edmon-Oslo-Low Back Surgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Edmon arm', 'interventionNames': ['Device: Edmon']}], 'interventions': [{'name': 'Edmon', 'type': 'DEVICE', 'description': 'Exhaled air will be analyzed for propofol', 'armGroupLabels': ['Edmon arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Johan Raeder', 'role': 'CONTACT', 'email': 'johan.rader@medisin.uio.no', 'phone': '+47 92249669'}, {'name': 'Johan Raeder', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Anesthesiology, Oslo University Hospital, Ullevaal', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Johan Raeder, PhD', 'role': 'CONTACT', 'email': 'johan.rader@medisin.uio.no', 'phone': '004792249669'}, {'name': 'Torsten Eken, PhD', 'role': 'CONTACT', 'email': 'torsten.eken@medisin.uio.no', 'phone': '004795079939'}], 'overallOfficials': [{'name': 'Kristin S 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', 'investigatorFullName': 'Johan C Ræder', 'investigatorAffiliation': 'Oslo University Hospital'}}}}