Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-07 @ 2:23 AM
Study NCT ID:
NCT03290859
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2017-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Race-Specific Propofol Titration to Effect for Procedural Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'C537417', 'term': 'Butyrylcholinesterase deficiency'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Compare in buccal samples the frequency of cytochrome allele carrier status in patients exhibiting sensitivity to propofol during the procedural time against published frequency data in Single Nucleotide Polymorphism database (dbSNP) by race.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2780}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the recovery times among races and ethnicities', 'timeFrame': 'Change from baseline up to 24 hours', 'description': 'Monitored using aggregate data for metrics of recovery times'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procedural Sedation'], 'conditions': ['Unconsciousness', 'Apnea, Postanesthetic', 'Sedative Overdose', 'Hypoxemia']}, 'descriptionModule': {'briefSummary': 'Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.', 'detailedDescription': 'The primary motivation in conducting this study is to conduct the implementation science, i.e., formalize and train, and retrain if needed, anesthesia providers in the standard practice of titrating infusion rate to effect and clinically evaluate the effect of race and ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make it less likely that patients from races known to be sensitive to propofol experience inadvertent overdosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites\n* Age range 18 - 80 years old\n* Patients whose race can be identified from the electronic patient information chart (EPIC)\n\nExclusion Criteria:\n\n* Patients who identify as multiracial in Epic\n* Patients who identify as Other in Epic\n* Patients who refuse to indicate their race in Epic\n* Patients whose race is listed as unknown in Epic'}, 'identificationModule': {'nctId': 'NCT03290859', 'briefTitle': 'Race-Specific Propofol Titration to Effect for Procedural Sedation', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy', 'orgStudyIdInfo': {'id': 'IRB201701064 - N'}, 'secondaryIdInfos': [{'id': 'UL1TR001427', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001427', 'type': 'NIH'}, {'id': 'OCR18882', 'type': 'OTHER', 'domain': 'University of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training intervention', 'description': 'Train anesthesia providers who deliver propofol sedation for GI endoscopy procedures to follow a uniform propofol monotherapy administration guideline to titrate propofol monotherapy infusion to effect according to a standardized protocol.', 'interventionNames': ['Procedure: Titrate propofol monotherapy infusion to effect']}, {'label': 'Effectiveness of training intervention', 'description': 'Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times.'}], 'interventions': [{'name': 'Titrate propofol monotherapy infusion to effect', 'type': 'PROCEDURE', 'description': 'Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.', 'armGroupLabels': ['Training intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Jeffrey White, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}