Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 2:46 PM
Study NCT ID:
NCT01282203
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2011-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor Abbott)'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Troponin T and CK-MB values were not collected in the study, therefore no conclusions can be made regarding the influence of volatile induction and maintenance anesthesia with Sevorane on myocardial ischemia markers.'}}, 'adverseEventsModule': {'timeFrame': 'Physicians reported all serious adverse events occurring during the induction, maintenance, and recovery phases of surgery until 30 days or 5 half-lives following termination of Sevorane. Mean (SD) total duration of anesthesia was 98.4 (67.2) minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery', 'otherNumAtRisk': 1122, 'otherNumAffected': 1, 'seriousNumAtRisk': 1122, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post-procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Loss of Consciousness of Patients Administered Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 minutes', 'description': 'Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Time to Awakening of Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '19.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every minute after anesthesia was stopped until the patient responded to a verbal command.', 'description': 'Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Time to Extubation of Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1010', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '127.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every minute after anesthesia was stopped until extubation occurred', 'description': 'Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': "Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': "Patients' Overall Impression of Anesthesia With Sevorane", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '476', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '627', 'groupId': 'OG000'}]}]}, {'title': 'Indifferent', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '995', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Before anesthesia', 'categories': [{'measurements': [{'value': '137.5', 'spread': '23.9', 'groupId': 'OG000'}]}]}, {'title': 'Induction anesthesia (after intubation)', 'categories': [{'measurements': [{'value': '125.3', 'spread': '22.3', 'groupId': 'OG000'}]}]}, {'title': 'After surgical incision', 'categories': [{'measurements': [{'value': '117.6', 'spread': '17.8', 'groupId': 'OG000'}]}]}, {'title': 'After extubation', 'categories': [{'measurements': [{'value': '125.5', 'spread': '14.1', 'groupId': 'OG000'}]}]}, {'title': 'One hour after surgery', 'categories': [{'measurements': [{'value': '124.2', 'spread': '12.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '995', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Before anesthesia', 'categories': [{'measurements': [{'value': '84.7', 'spread': '13.4', 'groupId': 'OG000'}]}]}, {'title': 'Induction anesthesia (after intubation)', 'categories': [{'measurements': [{'value': '78.5', 'spread': '30.2', 'groupId': 'OG000'}]}]}, {'title': 'After surgical incision', 'categories': [{'measurements': [{'value': '73.2', 'spread': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'After extubation', 'categories': [{'measurements': [{'value': '77.9', 'spread': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'One hour after surgery', 'categories': [{'measurements': [{'value': '76.9', 'spread': '10.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Before anesthesia', 'categories': [{'measurements': [{'value': '103.9', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Induction anesthesia (after intubation)', 'categories': [{'measurements': [{'value': '95.3', 'spread': '18.0', 'groupId': 'OG000'}]}]}, {'title': 'After surgical incision', 'categories': [{'measurements': [{'value': '89.5', 'spread': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'After extubation', 'categories': [{'measurements': [{'value': '95.5', 'spread': '13.0', 'groupId': 'OG000'}]}]}, {'title': 'One hour after surgery', 'categories': [{'measurements': [{'value': '95.0', 'spread': '12.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Before anesthesia', 'categories': [{'measurements': [{'value': '83.4', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Induction anesthesia (after intubation)', 'categories': [{'measurements': [{'value': '81.9', 'spread': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'After surgical incision', 'categories': [{'measurements': [{'value': '79.1', 'spread': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'After extubation', 'categories': [{'measurements': [{'value': '82.8', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'One hour after surgery', 'categories': [{'measurements': [{'value': '79.2', 'spread': '9.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Presence of Deviations in Electrocardiogram Assessments During Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Blockades (induction)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Blockades (maintenance)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Extrasystoles (induction)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Extrasystoles (maintenance)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Arrhythmia (induction)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Arrhythmia (maintenance)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial ischemia (induction)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial ischemia (maintenance)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During induction and maintenance of anesthesia', 'description': 'Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with valid data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Cardiac Troponin (if Available)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'timeFrame': 'Within 24 hours after anesthesia', 'description': 'Troponin T values measured within 24 hours of anesthesia were to be collected when available.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were available for the cardiac troponin outcome measure.'}, {'type': 'SECONDARY', 'title': 'Creatine Kinase Myocardial Isoenzyme (if Available)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'timeFrame': 'Within 24 hours after anesthesia', 'description': 'Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were available for the creatine kinase myocardial isoenzyme outcome measure.'}, {'type': 'SECONDARY', 'title': "Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Systolic blood pressure (T1- T0; n=1121)', 'categories': [{'measurements': [{'value': '0.271', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure (T2-T0; n=1121)', 'categories': [{'measurements': [{'value': '0.207', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure (T3 -T0; n=1005)', 'categories': [{'measurements': [{'value': '0.143', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure (T4 -T0; n=1105)', 'categories': [{'measurements': [{'value': '0.131', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure (Minimum -T0; n=1120)', 'categories': [{'measurements': [{'value': '0.213', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure (Maximum -T0; n=1120)', 'categories': [{'measurements': [{'value': '0.153', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (T1-T0; n=1119)', 'categories': [{'measurements': [{'value': '0.289', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (T2-T0; n=1119)', 'categories': [{'measurements': [{'value': '0.243', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (T3-T0; n=1005)', 'categories': [{'measurements': [{'value': '0.203', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (T4-T0; n=1105)', 'categories': [{'measurements': [{'value': '0.196', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (Minimum-T0; n=1118)', 'categories': [{'measurements': [{'value': '0.288', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (Maximum-T0; n=1118)', 'categories': [{'measurements': [{'value': '0.163', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial blood pressure (T1-T0; n=1101)', 'categories': [{'measurements': [{'value': '0.308', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial blood pressure (T2-T0; n=1102)', 'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial blood pressure (T3-T0; n=988)', 'categories': [{'measurements': [{'value': '0.199', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial blood pressure (T4-T0; n=1084)', 'categories': [{'measurements': [{'value': '0.196', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial blood pressure (Minimum-T0; n=1099)', 'categories': [{'measurements': [{'value': '0.288', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial blood pressure (Maximum-T0; n=1099)', 'categories': [{'measurements': [{'value': '0.177', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate (T1-T0; n=1117)', 'categories': [{'measurements': [{'value': '0.269', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate (T2-T0; n=1116)', 'categories': [{'measurements': [{'value': '0.245', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate (T3-T0; n=995)', 'categories': [{'measurements': [{'value': '-0.040', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate (T4-T0; n=1101)', 'categories': [{'measurements': [{'value': '-0.030', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate (Minimum-T0; n=1115)', 'categories': [{'measurements': [{'value': '0.223', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate (Maximum-T0; n=1116)', 'categories': [{'measurements': [{'value': '0.120', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': "The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively.", 'unitOfMeasure': "Spearman's correlation coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data at each time point were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'classes': [{'title': 'Exp w/ inh anesthesia (time to extubation; n=1010)', 'categories': [{'measurements': [{'value': '-0.720', 'groupId': 'OG000'}]}]}, {'title': 'Exp w/ inh anesthesia (time to awakening; n=1116)', 'categories': [{'measurements': [{'value': '-0.415', 'groupId': 'OG000'}]}]}, {'title': 'Exp w/ Sevorane (time to extubation; n=1010)', 'categories': [{'measurements': [{'value': '-0.681', 'groupId': 'OG000'}]}]}, {'title': 'Exp w/ Sevorane (time to awakening; n=1116)', 'categories': [{'measurements': [{'value': '-0.294', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command', 'description': "Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.", 'unitOfMeasure': "Spearman's correlation coefficient", 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data at each time point were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Anesthesiologists' Duration of Clinical Experience With Anesthesia", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'General Anesthesia', 'description': 'Duration of experience with general anesthesia.'}, {'id': 'OG001', 'title': 'Inhalation Anesthesia', 'description': 'Duration of experience with inhalation anesthesia.'}, {'id': 'OG002', 'title': 'Anesthesia With Sevorane', 'description': 'Duration of experience with Sevorane.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.)", 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of anesthesiologists participating in study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1122', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults Requiring Anesthesia for Surgery', 'description': 'Adult patients requiring general anesthesia for surgery'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '9.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '619', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '503', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2011-01-21', 'resultsFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2011-01-21', 'lastUpdatePostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-02', 'studyFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Loss of Consciousness of Patients Administered Anesthesia', 'timeFrame': 'Up to 10 minutes', 'description': 'Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.'}, {'measure': 'Time to Awakening of Patients', 'timeFrame': 'Every minute after anesthesia was stopped until the patient responded to a verbal command.', 'description': 'Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.'}, {'measure': 'Time to Extubation of Patients', 'timeFrame': 'Every minute after anesthesia was stopped until extubation occurred', 'description': 'Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.'}, {'measure': "Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia", 'timeFrame': 'Day 1', 'description': 'The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).'}, {'measure': "Patients' Overall Impression of Anesthesia With Sevorane", 'timeFrame': 'Day 1', 'description': 'After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other.'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.'}, {'measure': 'Heart Rate', 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': 'The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.'}, {'measure': 'Presence of Deviations in Electrocardiogram Assessments During Anesthesia', 'timeFrame': 'During induction and maintenance of anesthesia', 'description': 'Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).'}, {'measure': 'Cardiac Troponin (if Available)', 'timeFrame': 'Within 24 hours after anesthesia', 'description': 'Troponin T values measured within 24 hours of anesthesia were to be collected when available.'}, {'measure': 'Creatine Kinase Myocardial Isoenzyme (if Available)', 'timeFrame': 'Within 24 hours after anesthesia', 'description': 'Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.'}, {'measure': "Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia", 'timeFrame': 'Before starting anesthesia to one hour after the surgery', 'description': "The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively."}, {'measure': "Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening", 'timeFrame': 'Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command', 'description': "Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively."}, {'measure': "Anesthesiologists' Duration of Clinical Experience With Anesthesia", 'timeFrame': 'Baseline', 'description': "Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.)"}]}, 'conditionsModule': {'keywords': ['General surgery', 'General anesthesia', 'Inhalation anesthesia', 'Sevorane', 'Sevoflurane'], 'conditions': ['Anesthesia, General']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this post-marketing observational study is to collect data from the use of general anesthesia in patients undergoing any surgery to create local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on cardiovascular system in common clinical practice in Kazakhstan.', 'detailedDescription': 'This post-marketing observational study will be conducted in a prospective, multi-centre format. It is a non-interventional, observational study in which Sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be observed from the start of anesthesia through anesthesia end. Markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). Additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with Sevorane as a single anesthetic will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing planned or urgent surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist\n* Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Known sensitivity to sevoflurane or other anesthetic containing halogen\n* Known or suspected genetic susceptibility to malignant hyperthermia\n* Receiving regional anesthetic techniques\n* Receiving intravenous anesthesia\n* A history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics'}, 'identificationModule': {'nctId': 'NCT01282203', 'acronym': 'SEVOPROTECTION', 'briefTitle': 'Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Evaluation of VIMA With SEVOrane in Adult Patients Required General Anesthesia fOr Surgery in TErms of Quality of Anesthesia and Its Influence on Cardiovascular sysTem In commON Clinical Practice (SEVOPROTECTION)', 'orgStudyIdInfo': {'id': 'P12-638'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults requiring anesthesia for surgery', 'description': 'This post-marketing observational study will be conducted in a prospective, multi-centre format. It is a non-interventional, observational study in which Sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be observed from the start of anesthesia through anesthesia end. Markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). Additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with Sevorane as a single anesthetic will be assessed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51851', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '050012', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 54703', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51843', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51844', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 54705', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '020000', 'city': 'Kokshetau', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51842', 'geoPoint': {'lat': 53.28414, 'lon': 69.39364}}, {'zip': '110000', 'city': 'Kostanay', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51847', 'geoPoint': {'lat': 53.21435, 'lon': 63.62463}}, {'zip': '120008', 'city': 'Kyzylorda', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 64462', 'geoPoint': {'lat': 44.85278, 'lon': 65.50917}}, {'zip': '090000', 'city': 'Oral', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 54704', 'geoPoint': {'lat': 51.24601, 'lon': 51.42558}}, {'zip': '071403', 'city': 'Semey', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51845', 'geoPoint': {'lat': 50.42064, 'lon': 80.25025}}, {'zip': '160000', 'city': 'Shymkent', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 51848', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'zip': '100600', 'city': 'Zhezqazghan', 'country': 'Kazakhstan', 'facility': 'Site Reference ID/Investigator# 44446', 'geoPoint': {'lat': 47.79411, 'lon': 67.70628}}], 'overallOfficials': [{'name': 'Galyna Bryn, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Laboratories S.A., Ukraine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}