Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-12 @ 11:05 AM
Study NCT ID:
NCT02322502
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time of emergence from anesthesia', 'timeFrame': 'up to 15 minutes', 'description': 'time of emergence from anesthesia defined as time between cessation of anesthesia until patient is able to state his/her date of birth on command'}], 'secondaryOutcomes': [{'measure': 'Airway reactions (Incidence of intraoperative coughs, laryngospasm)', 'timeFrame': 'up to 2 hours', 'description': 'Incidence of intraoperative coughs (induction/maintenance) - non-inferiority design Incidence of intraoperative laryngospasm (induction/maintenance) Incidence of cough at emergence Incidence of laryngospasms at emergence'}, {'measure': 'Emergence times', 'timeFrame': 'up to 15 minutes', 'description': 'Time to remove laryngeal mask Time to open eyes on command Time to respond on command (press hand) Time to state the name on command Recovery Index (RI = 1 + Aldrete5min/\\[(2xextubation time) + 1 x opening eyes time)\\]'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laryngeal mask airway', 'desflurane', 'sevoflurane', 'propofol'], 'conditions': ['Anesthesia With Use of LMA (Laryngeal Mask Airway)']}, 'referencesModule': {'references': [{'pmid': '29916859', 'type': 'DERIVED', 'citation': 'Kowark A, Rossaint R, Puhringer F, Keszei AP, Fritz H, Froba G, Rex C, Haas H, Otto V, Coburn M; Study Collaborators. Emergence times and airway reactions during general anaesthesia with remifentanil and a laryngeal mask airway: A multicentre randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):588-597. doi: 10.1097/EJA.0000000000000852.'}, {'pmid': '26210907', 'type': 'DERIVED', 'citation': 'Stevanovic A, Rossaint R, Keszei AP, Fritz H, Froba G, Puhringer F, Coburn M. Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial. Trials. 2015 Jul 26;16:316. doi: 10.1186/s13063-015-0855-2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia.', 'detailedDescription': 'The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia (stating the date of birth) and second if desflurane is non-inferior in the occurrence of airway complications compared to sevoflurane or total intravenous anesthesia with propofol in the setting of laryngeal mask airway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned anesthesia with use of LMA (laryngeal mask airway)\n* Planned duration of anesthesia between 0.5 and 2 hours\n* Age between 18-75 years\n* Both gender\n* Body mass index (BMI) \\<35\n* ASA 1-3\n* Written informed consent prior to study participation\n\nExclusion Criteria:\n\n* Planned additional regional and local anesthesia\n* Contra-indication for the use of a laryngeal mask airway\n* Asthma\n* COPD IV\n* Known allergy or hypersensitivity to any drugs administered during this study\n* Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods\n* Participation in a drug or device trial within the previous 30 days.\n* Patients legally unable to give written informed consent.\n* Patients with severe psychiatric disorders\n* Recent (\\<6 months) history of alcohol or drug abuse\n* Patients with severe neuropsychiatric disorders\n* Non-fluency in German language'}, 'identificationModule': {'nctId': 'NCT02322502', 'briefTitle': 'Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)', 'orgStudyIdInfo': {'id': '14-073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'desflurane', 'description': 'Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application', 'interventionNames': ['Drug: Desflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane', 'description': 'Sevoflurane:\n\nDose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'propofol', 'description': 'Propofol Dose: 5-7 mg kg-1 h-1 to maintain a BIS index value between 40 and 60 Mode of administration: intravenous One application', 'interventionNames': ['Drug: propofol']}], 'interventions': [{'name': 'Desflurane', 'type': 'DRUG', 'otherNames': ['Suprane'], 'description': 'inhalation with laryngeal mask to maintain anaesthesia', 'armGroupLabels': ['desflurane']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevorane'], 'description': 'inhalation with laryngeal mask to maintain anaesthesia', 'armGroupLabels': ['sevoflurane']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['Anesia'], 'description': 'intravenous injection to maintain anaesthesia', 'armGroupLabels': ['propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'RWTH Aachen University; Department of Anesthesia', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '73764', 'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Kreiskliniken Reutlingen, Department of Anesthesia', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University Hospital Ulm, Department of Anesthesia', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Mark Coburn, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}