Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-03 @ 5:08 PM
Study NCT ID:
NCT02053766
Status:
TERMINATED
Last Update Posted:
2024-08-28
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anesthesia in Patients With Mitochondrial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028361', 'term': 'Mitochondrial Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'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'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maria.matuszczak@uth.tmc.edu', 'phone': '713 -500-5075', 'title': 'Maria Matuszczak', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lower back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mood change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'feeding difficulties', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 hours post anesthesia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '88.66', 'spread': '15.29', 'groupId': 'OG000'}, {'value': '89.20', 'spread': '4.76', 'groupId': 'OG001'}, {'value': '83.66', 'spread': '10.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'milligrams per decilitre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.'}, {'type': 'SECONDARY', 'title': 'Blood Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '7', 'groupId': 'OG000'}, {'value': '81.50', 'spread': '13.43', 'groupId': 'OG001'}, {'value': '93.75', 'spread': '16.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-operative', 'unitOfMeasure': 'milligrams per decilitre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 4 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 4 participants in the Propofol arm. Data were not collected for 2 participants in the Sevoflurane arm.'}, {'type': 'SECONDARY', 'title': 'Serum pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '7.39', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '7.37', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.'}, {'type': 'SECONDARY', 'title': 'Serum pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '7.36', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '7.40', 'spread': 'NA', 'comment': 'Standard Deviation not available since only 1 participant was analyzed for the assessment', 'groupId': 'OG001'}, {'value': '7.32', 'spread': '0.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-operative', 'description': 'The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 4 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 5 participants in the Propofol arm. Data were not collected for 4 participants in the Sevoflurane arm.'}, {'type': 'SECONDARY', 'title': 'Serum Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '25.50', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '24.04', 'spread': '3.66', 'groupId': 'OG001'}, {'value': '25.23', 'spread': '2.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.'}, {'type': 'SECONDARY', 'title': 'Serum Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '24.33', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '20', 'spread': 'NA', 'comment': 'Standard Deviation not available since only 1 participant was analyzed for the assessment', 'groupId': 'OG001'}, {'value': '26.5', 'spread': '2.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-operative', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 4 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 5 participants in the Propofol arm. Data were not collected for 4 participants in the Sevoflurane arm.'}, {'type': 'SECONDARY', 'title': 'Serum Lactate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '1.36', 'spread': '0.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for one participant in the Dexmedetomidine (Precedex®) arm. Data were not collected for one participant in the Propofol arm.'}, {'type': 'SECONDARY', 'title': 'Serum Lactate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '2.50', 'spread': '0.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-operative', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 3 participants in the Propofol arm. Data were not collected for 2 participants in the Sevoflurane arm.'}, {'type': 'SECONDARY', 'title': 'Serum Pyruvate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'milligrams per decilitre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 3 participants in the Propofol arm. Data were not collected for 2 participants in the Sevoflurane arm.'}, {'type': 'SECONDARY', 'title': 'Serum Pyruvate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'OG001', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'OG002', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.32', 'spread': 'NA', 'comment': 'Standard Deviation not available since only 1 participant was analyzed for the assessment', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-operative', 'unitOfMeasure': 'milligrams per decilitre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 5 participants in the Dexmedetomidine (Precedex®) arm. Data were not collected for 5 participants in the Propofol arm. Data were not collected for 3 participants in the Sevoflurane arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}, {'id': 'FG001', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'FG002', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.\n\nSevoflurane: Sevoflurane up to 8% will be administered to study subjects'}, {'id': 'BG001', 'title': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.\n\nDexmedetomidine: Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.'}, {'id': 'BG002', 'title': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.\n\nPropofol: Propofol up to 50 mcg/ kg/min will be administered to study subjects.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.22', 'groupId': 'BG000'}, {'value': '6.57', 'spread': '4.15', 'groupId': 'BG001'}, {'value': '4.33', 'spread': '2.33', 'groupId': 'BG002'}, {'value': '5.84', 'spread': '3.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-08', 'size': 889407, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-31T11:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'due to covid-19 we were not on track with enrollment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2014-01-31', 'resultsFirstSubmitDate': '2024-06-23', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-23', 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event', 'timeFrame': 'Up to 48 hours post anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Blood Glucose Level', 'timeFrame': 'Baseline'}, {'measure': 'Blood Glucose Level', 'timeFrame': '24 hours post-operative'}, {'measure': 'Serum pH', 'timeFrame': 'Baseline', 'description': 'The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.'}, {'measure': 'Serum pH', 'timeFrame': '24 hours post-operative', 'description': 'The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.'}, {'measure': 'Serum Bicarbonate', 'timeFrame': 'Baseline'}, {'measure': 'Serum Bicarbonate', 'timeFrame': '24 hours post-operative'}, {'measure': 'Serum Lactate', 'timeFrame': 'Baseline'}, {'measure': 'Serum Lactate', 'timeFrame': '24 hours post-operative'}, {'measure': 'Serum Pyruvate', 'timeFrame': 'Baseline'}, {'measure': 'Serum Pyruvate', 'timeFrame': '24 hours post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mitochondrial Diseases', 'Sevoflurane', 'Dexmedetomidine (Precedex®)', 'Propofol'], 'conditions': ['Mitochondrial Diseases']}, 'descriptionModule': {'briefSummary': 'This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.', 'detailedDescription': 'Study subjects undergoing a routine medical care non-emergent procedure will be randomized into three different groups to receive one of the following anesthetic agents; Sevoflurane, Propofol or Dexmedetomidine.\n\nThe primary outcome of this pilot study is to evaluate and compare the incidence of adverse events in mitochondrial patients undergoing a diagnostic or therapeutic procedure up to 48 hours post anesthesia. The secondary outcome is to compare the metabolic derangements between three study groups by comparing changes in blood sugar, serum pH, serum bicarbonate, serum lactate and serum pyruvate levels before, during and after anesthesia in the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must fulfill the following inclusion criteria:\n* Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.\n* Subject is willing and able to comply with all study requirements.\n* Subject is between 0 - 17 years of age.\n* Subject has been diagnosed with mitochondrial dysfunction based on modified Walker criteria.\n* Subject is scheduled to have a non-emergent diagnostic or therapeutic procedure for routine medical care requiring general anesthesia estimated to last at least one hour.\n* Subject is classified ASA I - IV\n\nExclusion Criteria:\n\nSubjects are not permitted to enroll in the study if any of the following criteria are met:\n\n* Subject is older than 17 years\n* Subject is pregnant\n* Subject is a nursing female and\n* Subject has participated in the same study within 48 hours\n* Subject is allergic or has had any adverse effect to any of the study agents in the past\n* Anesthesia time is less than one hour\n* Subject is classified ASA V'}, 'identificationModule': {'nctId': 'NCT02053766', 'briefTitle': 'Anesthesia in Patients With Mitochondrial Disease', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Anesthesia in Patients With Mitochondrial Disease', 'orgStudyIdInfo': {'id': 'HSC-MS-13-0600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane', 'description': 'In the Operating Room (OR) after applying routine monitors, anesthesia will be induced with a mask using Sevoflurane up to 8%. Sevoflurane will be used for maintenance for the rest of the procedure with dosage between 1.5% and 4%. Vitals will be monitored. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Sevoflurane will be turned off at the end of procedure.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine (Precedex®)', 'description': 'These subjects will receive Dexmedetomidine intravenously. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Precedex 1mcg/ kg will be given over 10 minutes. Infusion will be started using Precedex 1mcg/ kg/ hr and can be increased or decreased as needed. Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Precedex infusion will be stopped at the end of the procedure.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'These subjects will receive propofol for anesthesia maintenance. In the OR routine monitors will be placed. Vitals will be monitored. A loading dose of Propofol 2mg/ kg will be given over 2 minutes. Infusion will be started using Propofol 50 mcg/ kg/min and can be increased or decreased as needed (range 50-300mcg/kg/min). Fentanyl will be used as needed. Rocuronium will be used as needed for muscle relaxation. At the end of the procedure twitches will be evaluated and muscle relaxation will be reversed. Propofol infusion will be stopped at the end of the procedure.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Ultane'], 'description': 'Sevoflurane up to 8% will be administered to study subjects', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.', 'armGroupLabels': ['Dexmedetomidine (Precedex®)']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Propofol up to 50 mcg/ kg/min will be administered to study subjects.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Maria Matuszczak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '◦Professor of Anesthesiology-Clinical', 'investigatorFullName': 'Maria Matuszczak', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}