Viewing Study NCT01248234


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Study NCT ID: NCT01248234
Status: WITHDRAWN
Last Update Posted: 2012-07-16
First Post: 2010-11-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone?
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D005045', 'term': 'Etomidate'}], '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'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Did not begin', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2010-11-23', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure stability during anesthetic induction', 'timeFrame': '15 minutes', 'description': 'Blood pressure will be measures every minute for 15 minutes following anesthetic induction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly', 'hypertensive', 'anesthesia'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone.', 'detailedDescription': 'Same as above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 65 years old, with a history of hypertension.\n\nExclusion Criteria:\n\n* Patients less than 65 years old or without a history of hypertension.'}, 'identificationModule': {'nctId': 'NCT01248234', 'briefTitle': 'Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone?', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Does Administration of Etomidate and Propofol if the Anesthetic Induction of the Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngosacopy, When Compared to Propofol or Etomidate Alone?', 'orgStudyIdInfo': {'id': '2010-0097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Propofol alone will be used to put an elderly hypertensive patient to sleep for surgery.', 'interventionNames': ['Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Etomidate', 'description': 'Etomidate alone will be used to put an elderly hypertensive patient to sleep.', 'interventionNames': ['Drug: Etomidate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol and Etomidate', 'description': 'A combination of Etomidate and Propofol will be used to put an elderly hypertensive patient to sleep for surgery.', 'interventionNames': ['Drug: Propofol and Etomidate']}], 'interventions': [{'name': 'propofol', 'type': 'DRUG', 'description': 'Propofol 1mg/kg will be given once to put the patient to sleep for surgery.', 'armGroupLabels': ['Propofol']}, {'name': 'Etomidate', 'type': 'DRUG', 'description': 'Etomidate 0.3mg/kg will be given once to put the patient to sleep for surgery.', 'armGroupLabels': ['Etomidate']}, {'name': 'Propofol and Etomidate', 'type': 'DRUG', 'description': 'Etomidate 0.2mg/kg plus Propofol 0.5mg/kg will be given once to put the patient to sleep for surgery.', 'armGroupLabels': ['Propofol and Etomidate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Cynthia A Vaughn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}