Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT02624050
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008723', 'term': 'Methohexital'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abonavia@pennstatehealth.psu.edu', 'phone': '717-531-6140', 'title': 'Dr. Anthony Bonavia', 'organization': 'Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Hypotensive Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'pValueComment': 'Threshold for significance was p\\<0.05.', 'statisticalMethod': 'log-binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Refractory Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'pValueComment': 'Threshold of significance was \\<0.05', 'statisticalMethod': 'log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Each Hypotension Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': "This is the length of time that systolic blood pressure was either: (1) \\< 85 mmHg, or (2) a decrease of more than 30% from the individual's baseline SBP.", 'unitOfMeasure': 'min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'spread': '26', 'groupId': 'OG000'}, {'value': '126', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Systolic blood pressure will be measured through standard monitoring.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '12', 'groupId': 'OG000'}, {'value': '72', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Diastolic blood pressure will be measured through standard monitoring.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '14', 'groupId': 'OG000'}, {'value': '76', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Heart rate will be measured through standard monitoring.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'title': 'Time 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '205.68', 'spread': '231.37', 'groupId': 'OG000'}, {'value': '200.59', 'spread': '238.26', 'groupId': 'OG001'}]}]}, {'title': '3 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175.24', 'spread': '204.52', 'groupId': 'OG000'}, {'value': '166.04', 'spread': '222.77', 'groupId': 'OG001'}]}]}, {'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '212.34', 'spread': '230.44', 'groupId': 'OG000'}, {'value': '208.93', 'spread': '214.20', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '179.42', 'spread': '243.88', 'groupId': 'OG000'}, {'value': '168.39', 'spread': '185.79', 'groupId': 'OG001'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173.25', 'spread': '221.62', 'groupId': 'OG000'}, {'value': '147.32', 'spread': '163.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.277', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.\n\nThreshold for statistical significance was \\<0.05', 'statisticalMethod': 'Ratio of Geometric Means', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'This p-value is for 15 min after induction of anesthesia'}], 'paramType': 'MEAN', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were not available for some participants at some time points.'}, {'type': 'SECONDARY', 'title': 'Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'title': 'Time 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.89', 'spread': '52.57', 'groupId': 'OG000'}, {'value': '66.46', 'spread': '40.82', 'groupId': 'OG001'}]}]}, {'title': '3 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.86', 'spread': '63.46', 'groupId': 'OG000'}, {'value': '49.87', 'spread': '34.48', 'groupId': 'OG001'}]}]}, {'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.85', 'spread': '63.52', 'groupId': 'OG000'}, {'value': '57.29', 'spread': '31.95', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.96', 'spread': '36.97', 'groupId': 'OG000'}, {'value': '44.17', 'spread': '29.95', 'groupId': 'OG001'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.28', 'spread': '35.17', 'groupId': 'OG000'}, {'value': '39.56', 'spread': '27.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood Samples were not available for some participants at some time points.'}, {'type': 'SECONDARY', 'title': 'Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'title': 'Time 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.71', 'spread': '17.17', 'groupId': 'OG000'}, {'value': '18.85', 'spread': '16.15', 'groupId': 'OG001'}]}]}, {'title': '3 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.07', 'spread': '18.96', 'groupId': 'OG000'}, {'value': '19.56', 'spread': '16.84', 'groupId': 'OG001'}]}]}, {'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.42', 'spread': '18.70', 'groupId': 'OG000'}, {'value': '20.62', 'spread': '15.54', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.46', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '20.32', 'spread': '16.87', 'groupId': 'OG001'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.16', 'spread': '18.46', 'groupId': 'OG000'}, {'value': '17.63', 'spread': '16.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were not available for some participants at some time points'}, {'type': 'SECONDARY', 'title': 'Blood Levels of Arginine Vasopressin (AVP) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) for Participants Who Did Not Receive AVP for Refractory Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'title': 'Time 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.75', 'spread': '15.13', 'groupId': 'OG000'}, {'value': '29.76', 'spread': '16.17', 'groupId': 'OG001'}]}]}, {'title': '3 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.07', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '26.50', 'spread': '16.34', 'groupId': 'OG001'}]}]}, {'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.66', 'spread': '19.12', 'groupId': 'OG000'}, {'value': '23.99', 'spread': '13.71', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.36', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '16.37', 'spread': '9.18', 'groupId': 'OG001'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.76', 'spread': '15.00', 'groupId': 'OG000'}, {'value': '22.15', 'spread': '7.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction determined for participants who did not receive AVP for refractory hypotension', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were not available for some participants at some time points'}, {'type': 'SECONDARY', 'title': 'Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'classes': [{'title': 'Time 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.85', 'spread': '7.74', 'groupId': 'OG000'}, {'value': '33.28', 'spread': '28.96', 'groupId': 'OG001'}]}]}, {'title': '3 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.57', 'groupId': 'OG000'}, {'value': '30.24', 'spread': '25.13', 'groupId': 'OG001'}]}]}, {'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.73', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '29.89', 'spread': '21.28', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.93', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '22.61', 'spread': '12.25', 'groupId': 'OG001'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.85', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '63.86', 'spread': '45.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min), following anesthetic induction, determined for Participants who did not receive AVP for refractory hypotension', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples were not available for some participants at some time points'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'FG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was from 08/2016 through 08/2017 at the pre-anesthesia clinic and on the day of surgery in the pre-operative area.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.\n\nMethohexital: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'BG001', 'title': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.\n\nPropofol: Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '9', 'groupId': 'BG000'}, {'value': '60', 'spread': '14', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-12', 'size': 363673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-15T14:51', 'hasProtocol': True}, {'date': '2017-02-03', 'size': 170594, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-01-15T15:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2015-12-03', 'resultsFirstSubmitDate': '2019-01-20', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-12', 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Hypotensive Events', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Refractory Hypotension', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors'}, {'measure': 'Duration of Each Hypotension Episode', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': "This is the length of time that systolic blood pressure was either: (1) \\< 85 mmHg, or (2) a decrease of more than 30% from the individual's baseline SBP."}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Systolic blood pressure will be measured through standard monitoring.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Diastolic blood pressure will be measured through standard monitoring.'}, {'measure': 'Heart Rate', 'timeFrame': 'Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction', 'description': 'Heart rate will be measured through standard monitoring.'}, {'measure': 'Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction'}, {'measure': 'Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia)', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction'}, {'measure': 'Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction'}, {'measure': 'Blood Levels of Arginine Vasopressin (AVP) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) for Participants Who Did Not Receive AVP for Refractory Hypotension', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction determined for participants who did not receive AVP for refractory hypotension'}, {'measure': 'Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension', 'timeFrame': 'Time 0,3,5,10 and 15 min following anesthetic induction', 'description': 'Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min), following anesthetic induction, determined for Participants who did not receive AVP for refractory hypotension'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ACEI', 'ARB', 'Hypotension', 'General Anesthesia', 'Methohexital', 'Propofol'], 'conditions': ['Hypotension', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '11133595', 'type': 'BACKGROUND', 'citation': 'Bertrand M, Godet G, Meersschaert K, Brun L, Salcedo E, Coriat P. Should the angiotensin II antagonists be discontinued before surgery? Anesth Analg. 2001 Jan;92(1):26-30. doi: 10.1097/00000539-200101000-00006.'}, {'pmid': '3954922', 'type': 'BACKGROUND', 'citation': 'Carter JA, Clarke TN, Prys-Roberts C, Spelina KR. Restoration of baroreflex control of heart rate during recovery from anaesthesia. Br J Anaesth. 1986 Apr;58(4):415-21. doi: 10.1093/bja/58.4.415.'}, {'pmid': '3499095', 'type': 'BACKGROUND', 'citation': 'Cullen PM, Turtle M, Prys-Roberts C, Way WL, Dye J. Effect of propofol anesthesia on baroreflex activity in humans. Anesth Analg. 1987 Nov;66(11):1115-20.'}, {'pmid': '1575340', 'type': 'BACKGROUND', 'citation': 'Ebert TJ, Muzi M, Berens R, Goff D, Kampine JP. Sympathetic responses to induction of anesthesia in humans with propofol or etomidate. Anesthesiology. 1992 May;76(5):725-33. doi: 10.1097/00000542-199205000-00010.'}, {'pmid': '10320155', 'type': 'BACKGROUND', 'citation': 'Eyraud D, Brabant S, Nathalie D, Fleron MH, Gilles G, Bertrand M, Coriat P. Treatment of intraoperative refractory hypotension with terlipressin in patients chronically treated with an antagonist of the renin-angiotensin system. Anesth Analg. 1999 May;88(5):980-4. doi: 10.1097/00000539-199905000-00003.'}, {'pmid': '2994702', 'type': 'BACKGROUND', 'citation': 'Giudicelli JF, Berdeaux A, Edouard A, Richer C, Jacolot D. The effect of enalapril on baroreceptor mediated reflex function in normotensive subjects. Br J Clin Pharmacol. 1985 Sep;20(3):211-8. doi: 10.1111/j.1365-2125.1985.tb05063.x.'}, {'pmid': '3499244', 'type': 'BACKGROUND', 'citation': 'Gold MI, Abraham EC, Herrington C. A controlled investigation of propofol, thiopentone and methohexitone. Can J Anaesth. 1987 Sep;34(5):478-83. doi: 10.1007/BF03014354.'}, {'pmid': '24257383', 'type': 'BACKGROUND', 'citation': 'Komatsu R, You J, Mascha EJ, Sessler DI, Kasuya Y, Turan A. Anesthetic induction with etomidate, rather than propofol, is associated with increased 30-day mortality and cardiovascular morbidity after noncardiac surgery. Anesth Analg. 2013 Dec;117(6):1329-37. doi: 10.1213/ANE.0b013e318299a516.'}, {'pmid': '7168798', 'type': 'BACKGROUND', 'citation': 'Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.'}, {'pmid': '22854335', 'type': 'BACKGROUND', 'citation': 'Mets B. Management of hypotension associated with angiotensin-axis blockade and general anesthesia administration. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):156-67. doi: 10.1053/j.jvca.2012.06.014. Epub 2012 Jul 31. No abstract available.'}, {'pmid': '24464761', 'type': 'BACKGROUND', 'citation': 'Nielson E, Hennrikus E, Lehman E, Mets B. Angiotensin axis blockade, hypotension, and acute kidney injury in elective major orthopedic surgery. J Hosp Med. 2014 May;9(5):283-8. doi: 10.1002/jhm.2155. Epub 2014 Jan 24.'}, {'pmid': '1389822', 'type': 'BACKGROUND', 'citation': 'Price ML, Millar B, Grounds M, Cashman J. Changes in cardiac index and estimated systemic vascular resistance during induction of anaesthesia with thiopentone, methohexitone, propofol and etomidate. Br J Anaesth. 1992 Aug;69(2):172-6. doi: 10.1093/bja/69.2.172.'}]}, 'descriptionModule': {'briefSummary': 'Patient undergoing general anesthesia in elective surgery will be assigned to receive either methohexital or propofol general anesthesia. Hypotensive events during the first 15 minutes of induction will be compared between the groups to ascertain which drug is less likely to cause a hypotensive event.', 'detailedDescription': 'Patients taking angiotensin converting-enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) are susceptible to hypotensive events during general anesthesia. The purpose of this study is to determine if the use of either methohexital or propofol general anesthesias is more likely to result in hypotensive events in these patients during their induction. Hemodynamic metrics like blood pressure, mean arterial pressure, and heart rate will be monitored during the induction process, under both drugs, for use as the main metrics, as well as the need for vasopressors in response to patient hypotension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* treated for at least 6 weeks with ACEIs or ARB\n* undergoing elective surgery under general endotracheal anesthesia\n* ASA Physical Class I or II\n\nExclusion Criteria:\n\n* BMI \\>45kg/m\\^2\n* taking both ACEI and ARB\n* history of difficult intubation in the past\n* require rapid sequence induction and intubation\n* uncontrolled baseline blood pressure (SBP\\>180mmHg or DBP \\>110 mmHg) at anesthesia preoperative clinic visit\n* contraindication to the use of propofol or methohexital\n* significant coronary artery disease\n* history of systolic heart failure\n* history of renal failure (creatine level \\>2 mg/dL)'}, 'identificationModule': {'nctId': 'NCT02624050', 'briefTitle': 'Methohexital v Propofol as General Anesthetic in Patients on ACEIs or ARBs', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Comparison of Methohexital With Propofol for Anesthetic Induction in Patients Treated With an Antagonist of the Renin-Angiotensin System.', 'orgStudyIdInfo': {'id': 'STUDY00003830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methohexital', 'description': 'Methohexital will be administered intravenously as a general anesthetic at a dosage of 1.5mg per kg of patient body weight.', 'interventionNames': ['Drug: Methohexital']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Propofol will be administered intravenously as a general anesthetic at a dosage of 2.5mg per kg of patient body weight.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Methohexital', 'type': 'DRUG', 'otherNames': ['Brevital'], 'description': 'Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.', 'armGroupLabels': ['Methohexital']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17036', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S Hershey Medical Ctr', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Anthony Bonavia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anthony Bonavia', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}