Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01120405
Status:
COMPLETED
Last Update Posted:
2014-06-17
First Post:
2010-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014978', 'term': 'Xenon'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D005741', 'term': 'Noble Gases'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yannick.Lemanach@phri.ca', 'phone': '0012892606840', 'title': 'Yannick LE MANACH, MD, PhD', 'organization': 'Population Health Research Institute - Mc Master University, Hamilton CANADA'}, 'certainAgreement': {'otherDetails': 'Air Liquide Sante International may delay publication or disclosure for a term not exceeding eighteen (18) months with effect from the request in the event that Air Liquide Sante International wishes to seek protection of the results of the Trial by industrial property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events observed after the start of study drug administration and during postoperative 3-day period', 'description': 'Participants at risks are the patients from the Treated Set, ie randomised patients who received the study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)', 'otherNumAtRisk': 292, 'otherNumAffected': 79, 'seriousNumAtRisk': 292, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)', 'otherNumAtRisk': 294, 'otherNumAffected': 84, 'seriousNumAtRisk': 294, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subendocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Procedural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Operative Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shunt Trombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Troponin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gallblader Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 294, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Myocardial Necrosis (MN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-6.70', 'ciUpperLimit': '7.07', 'groupDescription': 'The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc \\< 10%.\n\nAs it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included.', 'statisticalMethod': 'Difference of proportion', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.'}], 'paramType': 'NUMBER', 'timeFrame': '3 Postoperative Days', 'description': 'Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '34'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.7715', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-3.90', 'ciUpperLimit': '5.25', 'statisticalMethod': 'Difference of proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 Postoperative days', 'description': 'At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '28'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.4763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '2.54', 'statisticalMethod': 'Difference of proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 Postoperative Days', 'description': 'Patients with Confirmed Myocardial Infarction (MI) by the Investigators', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cerebro-Vascular Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6533', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '1.14', 'statisticalMethod': 'Difference of proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 postoperative days', 'description': 'Patients with Cerebro-Vascular Event in the FAS', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Life-Threatening Arrhythmia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1559', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Difference of proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 Postoperative Days', 'description': 'Patients with Life-Threatening Arrhythmia in the FAS', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died From Cardiac Origin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 postoperative days', 'description': 'No patient died from a cardiac cause during the 3 postoperative days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '62'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '62'}]}]}], 'analyses': [{'pValue': '0.6056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '-4.74', 'ciUpperLimit': '8.13', 'statisticalMethod': 'Difference of proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 postoperative days', 'description': 'Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '146.1', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '147.3', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'Minimum SBP-Induction Time', 'categories': [{'measurements': [{'value': '90.6', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '90.3', 'spread': '20.7', 'groupId': 'OG001'}]}]}, {'title': 'Minimum SBP-Maintenance Time', 'categories': [{'measurements': [{'value': '94.8', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '83.8', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Minimum SBP- Awakening Time', 'categories': [{'measurements': [{'value': '123.8', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '117.6', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum SBP-Induction Time', 'categories': [{'measurements': [{'value': '156.0', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '153.6', 'spread': '29.6', 'groupId': 'OG001'}]}]}, {'title': 'Maximum SBP- Maintenance Time', 'categories': [{'measurements': [{'value': '157.8', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '144.6', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'Maximum SBP-Awakening Time', 'categories': [{'measurements': [{'value': '156.6', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '153.4', 'spread': '27.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From pre-induction to recovery of anesthesia', 'description': 'Repeated Systolic Blood Pressure measurements during the perioperative period', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}, {'type': 'SECONDARY', 'title': 'Vital Signs (SBP and DBP Changes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'title': 'SBP-Day 1', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '-14.2', 'spread': '26.8', 'groupId': 'OG001'}]}]}, {'title': 'SBP-Day 2', 'categories': [{'measurements': [{'value': '-10.8', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '25.6', 'groupId': 'OG001'}]}]}, {'title': 'SBP-Day 3', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'DBP-Day 1', 'categories': [{'measurements': [{'value': '-6.05', 'spread': '14.91', 'groupId': 'OG000'}, {'value': '-6.15', 'spread': '15.10', 'groupId': 'OG001'}]}]}, {'title': 'DBP- Day 2', 'categories': [{'measurements': [{'value': '-3.32', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '-1.46', 'spread': '13.41', 'groupId': 'OG001'}]}]}, {'title': 'DBP-Day 3', 'categories': [{'measurements': [{'value': '-3.73', 'spread': '14.05', 'groupId': 'OG000'}, {'value': '-2.61', 'spread': '13.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From pre-induction to Postoperative Day 3', 'description': 'Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Vital Signs (Heart Rate Changes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)'}], 'classes': [{'title': 'HR-Day 1', 'categories': [{'measurements': [{'value': '6.35', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': 'HR-Day 2', 'categories': [{'measurements': [{'value': '8.81', 'spread': '13.64', 'groupId': 'OG000'}, {'value': '9.85', 'spread': '12.93', 'groupId': 'OG001'}]}]}, {'title': 'HR-Day 3', 'categories': [{'measurements': [{'value': '6.44', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '8.90', 'spread': '14.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From pre-induction to Postoperative Day 3', 'description': 'Changes from baseline for Heart Rate (HR)', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chest Pain During the 3 Postoperative Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0 until Postoperative Day 3', 'description': 'Patients with Chest Pain reported at least once per day during the 3 Postoperative Days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Urine Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'OG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'classes': [{'categories': [{'measurements': [{'value': '1279.0', 'spread': '723.1', 'groupId': 'OG000'}, {'value': '1324.4', 'spread': '631.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 0 until Postoperative Day 1', 'description': 'Urine volume in milliliter (mL) during the first postoperative hours', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)'}, {'id': 'FG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '302'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '269'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '590', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xenon', 'description': '0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)'}, {'id': 'BG001', 'title': 'Sevoflurane', 'description': '0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '71.2', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '70.9', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '590', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with Baseline Cardiac Troponin (Central Laboratory)', 'classes': [{'title': '> 99th percentile', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': '≤ 99th percentile', 'categories': [{'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2010-05-04', 'resultsFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2010-05-07', 'lastUpdatePostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-20', 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Myocardial Necrosis (MN)', 'timeFrame': '3 Postoperative Days', 'description': 'Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)', 'timeFrame': '3 Postoperative days', 'description': 'At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)'}, {'measure': 'Number of Participants With Myocardial Infarction (MI)', 'timeFrame': '3 Postoperative Days', 'description': 'Patients with Confirmed Myocardial Infarction (MI) by the Investigators'}, {'measure': 'Number of Participants With Cerebro-Vascular Event', 'timeFrame': '3 postoperative days', 'description': 'Patients with Cerebro-Vascular Event in the FAS'}, {'measure': 'Number of Participants With Life-Threatening Arrhythmia', 'timeFrame': '3 Postoperative Days', 'description': 'Patients with Life-Threatening Arrhythmia in the FAS'}, {'measure': 'Number of Participants Who Died From Cardiac Origin', 'timeFrame': '3 postoperative days', 'description': 'No patient died from a cardiac cause during the 3 postoperative days.'}, {'measure': 'Number of Participants With Composite Endpoint', 'timeFrame': '3 postoperative days', 'description': 'Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin'}, {'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': 'From pre-induction to recovery of anesthesia', 'description': 'Repeated Systolic Blood Pressure measurements during the perioperative period'}, {'measure': 'Vital Signs (SBP and DBP Changes)', 'timeFrame': 'From pre-induction to Postoperative Day 3', 'description': 'Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)'}, {'measure': 'Vital Signs (Heart Rate Changes)', 'timeFrame': 'From pre-induction to Postoperative Day 3', 'description': 'Changes from baseline for Heart Rate (HR)'}, {'measure': 'Number of Participants With Chest Pain During the 3 Postoperative Days', 'timeFrame': 'From Day 0 until Postoperative Day 3', 'description': 'Patients with Chest Pain reported at least once per day during the 3 Postoperative Days'}, {'measure': 'Urine Output', 'timeFrame': 'From Day 0 until Postoperative Day 1', 'description': 'Urine volume in milliliter (mL) during the first postoperative hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xenon', 'Cardiac safety', 'Cardiovascular risk', 'Non cardiac surgery', 'Atherosclerotic vascular surgery'], 'conditions': ['Elevated Cardiac Risk', 'Coronary Arteries Disease Risk']}, 'descriptionModule': {'briefSummary': 'The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.', 'detailedDescription': 'The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;\n\nKey secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,\n* Cardiac ischaemic risk supported by:\n\n * History of myocardial infarction older than 1 month and/or\n * Documented Stable angina (asymptomatic ± medical treatment) and/or\n * History of coronary revascularisation, and/or\n * Surgical Risk Index ("Lee" index) ≥ 3.\n * Written informed consent\n\nExclusion Criteria:\n\n* Unstable angina within the last 30 days,\n* Non controlled arterial Hypertension .\n* Severe Cardiac heart Failure (NYHA IV)\n* Severe Chronic Obstructive Pulmonary Disease\n* Patient already randomized in another ongoing clinical trial\n* Patient with recent myocardial infarction (M.I) (less than one month )\n* Patient already included in a clinical trial\n* History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)\n* Malignant hyperthermia\n* Documented Elevated intracranial pressure\n* Preeclampsia or eclampsia\n* Pregnancy and lactation\n* Presumed uncooperativeness or legal incapacity'}, 'identificationModule': {'nctId': 'NCT01120405', 'acronym': 'CARVASAXe', 'briefTitle': 'Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Air Liquide Santé International'}, 'officialTitle': 'Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'EudraCT #2010-018703-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xenon', 'description': '0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)', 'interventionNames': ['Drug: Xenon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane', 'description': '0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Xenon', 'type': 'DRUG', 'otherNames': ['LENOXe'], 'armGroupLabels': ['Xenon']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevo'], 'armGroupLabels': ['sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Bas Rhin', 'country': 'France', 'facility': 'Nouvel Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '13915', 'city': 'Marseille', 'state': 'Bouches du Rhône', 'country': 'France', 'facility': 'CHU Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '14033 Cedex 9', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21079', 'city': 'Dijon', 'state': "Côte d'Or", 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '33076', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'Hopital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33604', 'city': 'Bordeaux', 'state': 'Gironde', 'country': 'France', 'facility': 'CHU Bordeaux Haut Lévèque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '35009', 'city': 'Rennes', 'state': 'Ille et Vilaine', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '59037 Cedex', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75013', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Chu Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Puy de Dôme', 'country': 'France', 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Val de Marne', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '86021 Cedex', 'city': 'Poitiers', 'state': 'Vienne', 'country': 'France', 'facility': 'CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Yanncik Le Manach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU PITIE SALPETRIERE, PARIS, FRANCE'}, {'name': 'Pierre CORIAT, MD Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU PITIE SALPETRIERE, PARIS, FRANCE'}, {'name': 'Benoit VALLET, MD Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Liquide Santé International', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurofins Biomnis', 'class': 'OTHER'}, {'name': 'Monitoring Force Group', 'class': 'INDUSTRY'}, {'name': 'Inferential', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}