Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-02 @ 5:34 PM
Study NCT ID:
NCT02840006
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.', 'timeFrame': 'in 24 hours', 'description': 'Will be measure the consumption of fentanyl in 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vasoconstrictor Agents', 'Vasodilator Agents'], 'conditions': ['Myocardial Revascularization', 'Spinal Anesthesia', 'Postoperative Care', 'Fentanyl']}, 'descriptionModule': {'briefSummary': 'CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a number of conditions that exceed the limits of cardiovascular stability, myocardial protection and other organs. Moreover, the combination of general anesthesia and spinal anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.\n\nMETHODS: Clinical, prospective, randomized and double covered study, approved by the Research Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of consent, were randomized and divided into two groups: GI - General and GII - General + subarachnoid. General anesthesia was induced according to the weight of each patient and maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5% hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using the Mann-Whitney test; the level of statistical significance was set at 5%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders\n* Underwent cardiac artery bypass surgery with cardiopulmonary bypass, with\n* No restriction on age\n* No restriction on ethnicity\n* No restriction on education or social class\n\nExclusion Criteria:\n\n* Patients with sternotomy provided; those\n* Urgent surgery and/or emergency\n* Patient was with signs of shock\n* Patients with chronic renal failure\n* Patients with liver disorders\n* Tracheostomy patients\n* Patients with presence of use of mechanical ventilatory support;\n* Patients with physical disabilities; bedridden and wheelchair users.\n* Patients to withdraw the Consent and Informed\n* Patients who eventually had to be re-operated in the presence also of the mechanical ventilatory support.'}, 'identificationModule': {'nctId': 'NCT02840006', 'briefTitle': 'Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Sapucai'}, 'orgStudyIdInfo': {'id': 'MEDC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia only', 'description': 'Anesthetic induction with etomidate 0,3 a 0,4 mg.kg-1, citrate fentanyl 5 mcg.kg-1 and atracurium 0,5.kg-1', 'interventionNames': ['Procedure: General anesthesia only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia associated spinal anesthesia', 'description': 'spinal anesthesia using bupivacaine 0,5% hyperbaric 20 mg, morphine 200 mcg, set trendeleburg for 10 minutes, sensitive test in T1. Anesthetic induction with etomidate 0,3 a 0,4 mg.kg-1, citrate fentanyl 5 mcg.kg-1 and atracurium 0,5.kg-1.', 'interventionNames': ['Procedure: General anesthesia and Spinal anesthesia']}], 'interventions': [{'name': 'General anesthesia only', 'type': 'PROCEDURE', 'description': 'Induction drugs: Citrate of fentanyl, atracurium, etomidate', 'armGroupLabels': ['General anesthesia only']}, {'name': 'General anesthesia and Spinal anesthesia', 'type': 'PROCEDURE', 'description': 'Induction drugs: Citrate of fentanyl, atracurium, etomidate Spinal anesthesia: Bupivacaine hyperbaric, Morphine', 'armGroupLabels': ['General anesthesia associated spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clinicas Samuel Libânio', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}, {'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Univas', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniel Gioielli de Castilho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Daniel Gioielli de Castilho', 'investigatorAffiliation': 'Universidade do Vale do Sapucai'}}}}