Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT02199067
Status:
TERMINATED
Last Update Posted:
2019-04-17
First Post:
2014-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Exhaled Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'arterial blood samples (serum)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'technical difficulties of probe measurement', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exhaled propofol levels in breathing gas', 'timeFrame': 'continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)'}], 'secondaryOutcomes': [{'measure': 'propofol concentration in arterial blood serum', 'timeFrame': 'samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours'}, {'measure': 'Bispectral Index (BIS)', 'timeFrame': 'continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anaesthesia With Propofol']}, 'referencesModule': {'references': [{'pmid': '40895257', 'type': 'DERIVED', 'citation': 'Schmidt S, Ihmsen H, Munster T, Schuttler J, Jeleazcov C, Wehrfritz A. Determination of the Long-Term Stability of Propofol in Human Plasma Frozen for Eight Years and Quantified by UHPLC-MS/MS. Int J Anal Chem. 2025 Aug 22;2025:7533068. doi: 10.1155/ianc/7533068. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total intravenous anaesthesia with propofol is done only by experience of the anaesthetist or according to pharmacokinetic models. In this study we want to investigate if the exhaled fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG \\& Co. KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol levels with the Bispectral Index (BIS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* patients undergoing elective surgery\n* total intravenous anaesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anaesthesiologists) classification I \\& II\n* Body-Mass-Index \\< 35\n* elective surgery with the necessity of an arterial catheter\n\nExclusion Criteria:\n\n* chronic obstructive lung disease\n* bronchial asthma\n* smokers with more than 5 packyears\n* peripheral artery occlusive disease\n* diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02199067', 'acronym': 'PIAG1', 'briefTitle': 'Measurement of Exhaled Propofol', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Measurement of Exhaled Propofol During a Total Intravenous Anesthesia With Propofol and Remifentanil', 'orgStudyIdInfo': {'id': 'PIAG1'}}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Tino Münster', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}