Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-04 @ 10:18 PM
Study NCT ID:
NCT04226495
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sufentanil Infusion vs Sufentanil Bolus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.songster@unmc.edu', 'phone': '308-520-2847', 'title': 'Jeffrey Songster', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Procedure end time to discharge from hospital, an average of 4 days.', 'description': 'AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship.\n\nAny reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.', 'eventGroups': [{'id': 'EG000', 'title': 'Sufentanil Bolus', 'description': 'Sufentanil Bolus: Intra-operative sufentanil bolus', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sufentanil Infusion', 'description': 'Sufentanil Infusion: Intra-operative sufentanil infusion', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 5, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypotension', 'notes': 'Hypotension requiring vasopressor support in ICU.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute left MCA stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergent OR procedure', 'notes': 'Return to OR for bleeding.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Extubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sufentanil Bolus', 'description': 'Sufentanil Bolus: Intra-operative sufentanil bolus'}, {'id': 'OG001', 'title': 'Sufentanil Infusion', 'description': 'Sufentanil Infusion: Intra-operative sufentanil infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '230.5', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '794'}, {'value': '242.4', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '691'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.', 'description': 'We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will decrease time to extubation from OR stop data collection time point by 60 minutes compared to sufentanil bolus administration.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The participant number represent the number of participant whom made it to this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sufentanil Bolus', 'description': 'Sufentanil Bolus: Intra-operative sufentanil bolus'}, {'id': 'OG001', 'title': 'Sufentanil Infusion', 'description': 'Sufentanil Infusion: Intra-operative sufentanil infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.', 'description': 'We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will result in a lower plasma concentration of sufentanil at time of arrival to ICU and if the plasma concentration correlates with time to extubation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Lab concentration was measured on arrival to ICU. Not all subjects had this lab available, thus the inconsistency of numbers from the participant flow module.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sufentanil Bolus', 'description': 'Sufentanil Bolus: Intra-operative sufentanil bolus'}, {'id': 'FG001', 'title': 'Sufentanil Infusion', 'description': 'Sufentanil Infusion: Intra-operative sufentanil infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'PI discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sufentanil Bolus', 'description': 'Sufentanil Bolus: Intra-operative sufentanil bolus'}, {'id': 'BG001', 'title': 'Sufentanil Infusion', 'description': 'Sufentanil Infusion: Intra-operative sufentanil infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-09-30', 'size': 234463, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-11T16:30', 'hasProtocol': True}, {'date': '2021-06-17', 'size': 151379, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-08T14:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2020-01-09', 'resultsFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-06', 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Extubation', 'timeFrame': 'Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.', 'description': 'We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will decrease time to extubation from OR stop data collection time point by 60 minutes compared to sufentanil bolus administration.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration', 'timeFrame': 'Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.', 'description': 'We will determine if sufentanil infusion administration intra-operatively during routine cardiac surgery will result in a lower plasma concentration of sufentanil at time of arrival to ICU and if the plasma concentration correlates with time to extubation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.', 'detailedDescription': 'This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR\n* 19 to 80 years old\n* Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic visit.\n* Inpatient subject that is scheduled (greater than 24hrs in advance) for a non-emergency cardiac surgical case\n\nExclusion Criteria:\n\n* Sufentanil allergy\n* EF less than or equal to 30%\n* Moderate or severe right ventricular dysfunction,\n* Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily bronchodilator therapy.\n* End Stage Renal Disease on Dialysis\n* Chronic Kidney Disease with GFR \\<30\n* Sternotomy Re-do\n* Emergency surgery\n* Greater than 4 units of RBCs or FFP combined\n* Mechanical circulatory support post-operatively such as ECMO, IABP, Impella\n* Not eligible for rapid wean extubation protocol\n* Requires infusion of sedative medication required during ICU admission\n* Greater than or equal to 15 minute ICU hold within PACU'}, 'identificationModule': {'nctId': 'NCT04226495', 'briefTitle': 'Sufentanil Infusion vs Sufentanil Bolus', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery', 'orgStudyIdInfo': {'id': '0520-20-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sufentanil Bolus', 'description': 'medication in scheduled doses (bolus)', 'interventionNames': ['Drug: Sufentanil Bolus']}, {'type': 'EXPERIMENTAL', 'label': 'Sufentanil Infusion', 'description': 'medication in a slow trickle (infusion)', 'interventionNames': ['Drug: Sufentanil Infusion']}], 'interventions': [{'name': 'Sufentanil Infusion', 'type': 'DRUG', 'otherNames': ['Sufentanil'], 'description': 'Intra-operative sufentanil infusion', 'armGroupLabels': ['Sufentanil Infusion']}, {'name': 'Sufentanil Bolus', 'type': 'DRUG', 'otherNames': ['Sufentanil'], 'description': 'Intra-operative sufentanil bolus', 'armGroupLabels': ['Sufentanil Bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Jeffrey C Songster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}