Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT00532402
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2007-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-29', 'studyFirstSubmitDate': '2007-09-18', 'studyFirstSubmitQcDate': '2007-09-19', 'lastUpdatePostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Monitoring', 'Breathing Gas', 'Propofol'], 'conditions': ['General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '16571975', 'type': 'RESULT', 'citation': 'Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Gerlach K, Gehring H. Discontinuous monitoring of propofol concentrations in expired alveolar gas and in arterial and venous plasma during artificial ventilation. Anesthesiology. 2006 Apr;104(4):786-90. doi: 10.1097/00000542-200604000-00024.'}]}, 'descriptionModule': {'briefSummary': 'This study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas.\n\nStudy hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having general anesthesia for cardiac and non-cardiac operation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient destined for general anesthesia\n\nExclusion Criteria:\n\n* Heart insufficiency NYHA IV\n* Allergy to propofol'}, 'identificationModule': {'nctId': 'NCT00532402', 'briefTitle': 'Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas - Compared With Propofol Concentration in Plasma (Before and) After Lung Passage and Neurophysiological Parameters', 'orgStudyIdInfo': {'id': 'P-A-S-1'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D-23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Dept. of Anesthesiology , UK-SH, Campus Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': 'D-23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Dept. of Anesthesiology, UK-SH, Campus Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Hartmut Gehring, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept of Anesthesiology, UK-SH, Campus Luebeck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Martin Grossherr', 'investigatorAffiliation': 'University of Luebeck'}}}}