Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT04291794
Status:
UNKNOWN
Last Update Posted:
2020-03-02
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and outcomes Assessor will not know group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-11-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial pressure after 2 minutes', 'timeFrame': '2 minutes after general anesthesia induction', 'description': 'Mean arterial pressure using non-invasive device'}, {'measure': 'Mean arterial pressure after 4 minutes', 'timeFrame': '4 minutes after general anesthesia induction minutes after general anesthesia induction', 'description': 'Mean arterial pressure using non-invasive device'}, {'measure': 'Mean arterial pressure after 6 minutes', 'timeFrame': '6 minutes after general anesthesia induction minutes after general anesthesia induction', 'description': 'Mean arterial pressure using non-invasive device'}, {'measure': 'Mean arterial pressure after 8 minutes', 'timeFrame': '8 minutes after general anesthesia induction minutes after general anesthesia induction', 'description': 'Mean arterial pressure using non-invasive device'}, {'measure': 'Mean arterial pressure after 10 minutes', 'timeFrame': '10 minutes after general anesthesia induction minutes after general anesthesia induction', 'description': 'Mean arterial pressure using non-invasive device'}], 'secondaryOutcomes': [{'measure': 'Heart Rate after 2 minutes', 'timeFrame': '2 minutes after general anesthesia induction', 'description': 'Heart rate (pulse rate) using non-invasive device.'}, {'measure': 'Heart Rate after 4 minutes', 'timeFrame': '4 minutes after general anesthesia induction', 'description': 'Heart rate (pulse rate) using non-invasive device.'}, {'measure': 'Heart Rate after 6 minutes', 'timeFrame': '6 minutes after general anesthesia induction', 'description': 'Heart rate (pulse rate) using non-invasive device.'}, {'measure': 'Heart Rate after 8 minutes', 'timeFrame': '8 minutes after general anesthesia induction', 'description': 'Heart rate (pulse rate) using non-invasive device.'}, {'measure': 'Heart Rate after 10 minutes', 'timeFrame': '10 minutes after general anesthesia induction', 'description': 'Heart rate (pulse rate) using non-invasive device.'}, {'measure': 'Bispectral Index after 2 minutes', 'timeFrame': '2 minutes after general anesthesia induction', 'description': 'Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.'}, {'measure': 'Bispectral Index after 4 minutes', 'timeFrame': '4 minutes after general anesthesia induction', 'description': 'Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.'}, {'measure': 'Bispectral Index after 6 minutes', 'timeFrame': '6 minutes after general anesthesia induction', 'description': 'Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.'}, {'measure': 'Bispectral Index after 8 minutes', 'timeFrame': '8 minutes after general anesthesia induction', 'description': 'Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.'}, {'measure': 'Bispectral Index after 10 minutes', 'timeFrame': '10 minutes after general anesthesia induction', 'description': 'Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension on Induction', 'Hypnotic Intoxication']}, 'descriptionModule': {'briefSummary': 'To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.', 'detailedDescription': 'To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for general anesthesia;\n* No contraindication for propofol.\n\nExclusion Criteria:\n\n* Data loss;\n* Protocol violation.'}, 'identificationModule': {'nctId': 'NCT04291794', 'briefTitle': 'Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia University Hospital'}, 'officialTitle': 'Mean Arterial Pressure Reduction During the First Ten Minutes After General Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion: Superiority Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'tccgui2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional bolus induction', 'description': 'Hypnotic component of general anesthesia induction will be a single bolus of propofol 2mg/kg followed by turning on sevoflurane 2% at a fresh gas flow of 2L/min.', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Target-controlled induction', 'description': 'Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.', 'interventionNames': ['Drug: Propofol Injection [Diprivan]']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': '2mg/kg single bolus', 'armGroupLabels': ['Conventional bolus induction']}, {'name': 'Propofol Injection [Diprivan]', 'type': 'DRUG', 'description': 'Tritiated Target-Controlled Infusion', 'armGroupLabels': ['Target-controlled induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000000', 'city': 'BrasÃlia', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Universitário de Brasilia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'centralContacts': [{'name': 'Gabriel MN Guimaraes, MSc', 'role': 'CONTACT', 'email': 'gabrielmng@gmail.com', 'phone': '+5561996455997'}], 'overallOfficials': [{'name': 'Gabriel MN Guimaraes, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After study ends', 'ipdSharing': 'YES', 'description': 'Plan to share at open database.', 'accessCriteria': 'Open'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Voluntary professor', 'investigatorFullName': 'Gabriel Magalhaes Nunes Guimaraes', 'investigatorAffiliation': 'Brasilia University Hospital'}}}}