Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 7:29 AM
Study NCT ID:
NCT01195103
Status:
TERMINATED
Last Update Posted:
2012-06-29
First Post:
2010-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C472965', 'term': 'fospropofol'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leslie.john@mayo.edu', 'phone': '480-301-8000', 'title': 'John B Leslie MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was terminated early because funding was terminated by the funding source.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation.', 'description': 'No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': '10 mg/kg Lusedra', 'description': '10 mg/kg Lusedra initial bolus', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '6.5 mg/kg Lusedra', 'description': '6.5 mg/kg Lusedra initial bolus', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo + Midazolam', 'description': "Placebo initial bolus with dose of midazolam based on patient's weight", 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'deep sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'delayed recovery from sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'puritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sedation Within 4 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg/kg Lusedra', 'description': '10 mg/kg Lusedra initial bolus'}, {'id': 'OG001', 'title': '6.5 mg/kg Lusedra', 'description': '6.5 mg/kg Lusedra initial bolus'}, {'id': 'OG002', 'title': 'Placebo + Midazolam', 'description': "Placebo initial bolus with dose of midazolam based on patient's weight"}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 4 minutes after administration of first bolus of study drug', 'description': 'Percentage of patients achieving a Modified Observer\'s Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer\'s Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 mg/kg Lusedra', 'description': '10 mg/kg Lusedra initial bolus'}, {'id': 'FG001', 'title': '6.5 mg/kg Lusedra', 'description': '6.5 mg/kg Lusedra initial bolus'}, {'id': 'FG002', 'title': 'Placebo + Midazolam', 'description': "Placebo initial bolus with dose of midazolam based on patient's weight"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient withdrew after randomization but before received study drug.', 'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from Mayo Clinic, Arizona from March 1 - 11, 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '10 mg/kg Lusedra', 'description': '10 mg/kg Lusedra initial bolus'}, {'id': 'BG001', 'title': '6.5 mg/kg Lusedra', 'description': '6.5 mg/kg Lusedra initial bolus'}, {'id': 'BG002', 'title': 'Placebo + Midazolam', 'description': "Placebo initial bolus with dose of midazolam based on patient's weight"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '71.5', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '72', 'spread': '12', 'groupId': 'BG002'}, {'value': '72.6', 'spread': '8.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Funding terminated by funding source.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2010-09-01', 'resultsFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2010-09-02', 'lastUpdatePostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-01', 'studyFirstPostDateStruct': {'date': '2010-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sedation Within 4 Minutes', 'timeFrame': 'approximately 4 minutes after administration of first bolus of study drug', 'description': 'Percentage of patients achieving a Modified Observer\'s Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer\'s Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Procedural sedation', 'Regional Anesthesia block', 'Orthopedic surgery', 'Lusedra', 'Fospropofol disodium', 'Midazolam'], 'conditions': ['Procedural Sedation', 'Regional Anesthesia Block', 'Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': 'How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?', 'detailedDescription': 'The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a superior recovery profile compared to midazolam when used as a rescue comparator. While this study will only enroll patients undergoing regional blocks prior to orthopedic surgery, the clinical utility and value of the larger initial intravenous dosing for Lusedra may be evident for many different monitored anesthesia care anesthetic management situations requiring rapid and effective onset of effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing elective orthopedic surgery\n* With a regional block prior to surgery\n* Able to consent and complete the assessments and procedures\n* If female, must be surgically sterile, postmenopausal, or not pregnant or lactating and using an acceptable method of birth control for at least 1 month prior to surgery with a negative urine pregnancy test at screening\n* American Society of Anesthesiologists Physical Classification System status category P1 to P4\n\nExclusion Criteria:\n\n* History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine\n* Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated'}, 'identificationModule': {'nctId': 'NCT01195103', 'briefTitle': 'Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective Randomized Study to Assess the Efficacy and Safety of Bolus-dose Lusedra (Fospropofol Disodium) 6.5 mg/kg or 10 mg/kg Versus a Placebo (With Midazolam Rescue) for Minimal-to-moderate Sedation in Patients Undergoing Procedural Sedation for Regional Anesthesia Blocks Prior to Orthopedic Surgery', 'orgStudyIdInfo': {'id': '10-000721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mg/kg Lusedra', 'description': '10 mg/kg Lusedra initial bolus.', 'interventionNames': ['Drug: Fospropofol disodium', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6.5 mg/kg Lusedra', 'description': '6.5 mg/kg Lusedra initial bolus.', 'interventionNames': ['Drug: Fospropofol disodium', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Midazolam', 'description': "Placebo initial bolus with dose of midazolam based on patient's weight", 'interventionNames': ['Drug: Placebo + Midazolam', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Fospropofol disodium', 'type': 'DRUG', 'otherNames': ['Lusedra'], 'description': '10 mg/kg bolus', 'armGroupLabels': ['10 mg/kg Lusedra']}, {'name': 'Fospropofol disodium', 'type': 'DRUG', 'otherNames': ['Lusedra'], 'description': '6.5 mg/kg bolus', 'armGroupLabels': ['6.5 mg/kg Lusedra']}, {'name': 'Placebo + Midazolam', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': "Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients \\<60 kg; 1.5 mg for patients ≥60 kg to \\<90 kg; or 2 mg for patients ≥90 kg", 'armGroupLabels': ['Placebo + Midazolam']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentanyl Citrate', 'Sublimaze'], 'description': 'All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \\<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.', 'armGroupLabels': ['10 mg/kg Lusedra', '6.5 mg/kg Lusedra', 'Placebo + Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'John B Leslie, MD MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eisai Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'John B Leslie MD MBA', 'oldOrganization': 'Mayo Clinic'}}}}