Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-31 @ 12:31 PM
Study NCT ID:
NCT01452256
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2011-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major complications as defined as ≥ grade IIIa according to classification of surgical complications from Dindo et al. after lung resection with one-lung ventilation during hospitalization', 'timeFrame': 'postoperative phase until discharge; 6 month after surgery'}], 'secondaryOutcomes': [{'measure': 'Major complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. after dimissio up to 6 months after surgery', 'timeFrame': 'postoperative phase until discharge, 6 month postoperative'}, {'measure': 'Perioperative inflammatory mediators TNF-α, IL-6, IL-8, sICAM-1, MCP-1, MIP-2 in blood (correlation to complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. during hospitalization)', 'timeFrame': 'postoperative phase until discharge'}]}, 'conditionsModule': {'conditions': ['Thoracic Surgery']}, 'referencesModule': {'references': [{'pmid': '34132704', 'type': 'DERIVED', 'citation': 'Neff TA, Braun J, Rana D, Puhan M, Filipovic M, Seeberger M, Stuber F, Neff SB, Beck-Schimmer B, Schlapfer M. Interleukin-6 Is an Early Plasma Marker of Severe Postoperative Complications in Thoracic Surgery: Exploratory Results From a Substudy of a Randomized Controlled Multicenter Trial. Anesth Analg. 2022 Jan 1;134(1):123-132. doi: 10.1213/ANE.0000000000005639.'}]}, 'descriptionModule': {'briefSummary': 'Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery.\n\nHalothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide\n\n* Trial with medicinal product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: • Elective thoracic surgery (thoracotomy, thoracoscopy)\n\n* Lung resection\n* One-lung ventilation\n* Adults (18-80 years of age)\n* ASA classification I - III\n* Written consent (signature from patient)\n\nExclusion criteria:\n\n* Known hypersensitivity or suspected allergy to propofol, soja or egg proteins\n* Known hypersensitivity to volatile anesthetics (malignant hyperthermia)\n* Medication with high dosage of statins\n* Therapy with cyclosporin\n* Severe renal impairment (GFR \\< 30 ml/min)\n* Oral steroid treatment at present or stopped less than 3 months before surgery\n* Inflammatory processes (non-pulmonary or pulmonary): elevated C-reactive protein level (\\> 20 mg/l) or leukocytosis (leukocytes \\> 10x103/?l) or body temperature \\> 37°C)\n* Pregnancy\n* Breast feeding\n* The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion'}, 'identificationModule': {'nctId': 'NCT01452256', 'briefTitle': 'Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery', 'orgStudyIdInfo': {'id': 'KEK-ZH Nr.2011-0092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desflurane', 'description': 'Desflurane for pharmacological conditioning', 'interventionNames': ['Drug: Desflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Desflurane', 'type': 'DRUG', 'description': '4-6 Vol %', 'armGroupLabels': ['Desflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'TIVA to achieve BIS value of 40-60', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}, {'name': 'Beatrice Beck Schimmer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Anaesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, {'name': 'Kantonsspital Münsterlingen', 'class': 'OTHER'}, {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}