Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-30 @ 8:09 PM
Study NCT ID:
NCT02442232
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2015-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '10 minutes'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '10 minutes'}, {'measure': 'Mean blood pressure', 'timeFrame': '10 minutes'}, {'measure': 'Heart rate', 'timeFrame': '10 minutes'}, {'measure': 'Plasma nitrite levels', 'timeFrame': '10 minutes'}, {'measure': 'Plasma nitrate levels', 'timeFrame': '10 minutes'}]}, 'conditionsModule': {'conditions': ['Hemodynamic Responses to Propofol']}, 'referencesModule': {'references': [{'pmid': '33410970', 'type': 'DERIVED', 'citation': 'Oliveira-Paula GH, Coeli-Lacchini FB, Ferezin LP, Ferreira GC, Pinheiro LC, Paula-Garcia WN, Garcia LV, Tanus-Santos JE, Lacchini R. Arginase II polymorphisms modify the hypotensive responses to propofol by affecting nitric oxide bioavailability. Eur J Clin Pharmacol. 2021 Jun;77(6):869-877. doi: 10.1007/s00228-020-03059-9. Epub 2021 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after propofol anesthesia. In addition, the investigators will evaluate the effects of propofol anesthesia on biomarkers related to nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under propofol anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II\n* BMI lower 30 kg/m2\n\nExclusion Criteria:\n\n* Severe hypertension\n* Previous stroke\n* Previous infarction\n* Uncontrolled respiratory, renal, hepatic and hematological diseases.'}, 'identificationModule': {'nctId': 'NCT02442232', 'briefTitle': 'Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico'}, 'orgStudyIdInfo': {'id': 'CNPq'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normotensive'}, {'label': 'Hypertensive taking ACEi'}, {'label': 'Hypertensive not taking ACEi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Gustavo Henrique Oliveira de Paula', 'investigatorAffiliation': 'University of Sao Paulo'}}}}