Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-26 @ 1:39 PM
Study NCT ID:
NCT03497351
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2018-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009529', 'term': 'Nicardipine'}, {'id': 'C015568', 'term': 'urapidil'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SVV', 'timeFrame': 'The period between the begining of anesthesia and the end of operation.', 'description': 'stroke volume variation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Surgery']}, 'descriptionModule': {'briefSummary': "SVV is clinically affected by a variety of factors, such as abdominal pressure, body position, tidal volume, type and temperature of liquid treatment, etc. There are few reports on the effects of drugs on SVV.\n\nIn clinical anesthesia, surgical stimulation and stress can affect patient hemodynamic stability, used in intraoperative vascular active drug is inevitable, they shrink or dilate blood vessels, speed up or slow down the heart rate, makes the ventricular preload and corresponding changes in the SV. Now, there is a study on SVV and PPV in patients with hypertension, but there are few reports on the effect of blood pressure drugs on the changes in patients' threshold."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA Ⅰ-Ⅲ\n2. body mass index (BMI) 18-26kg/m2.\n3. Hypertension and non-hypertensive patients\n4. diabetic no complications\n5. no lung, liver, kidney and blood system diseases\n6. preoperative examination is basically normal.\n\nExclusion Criteria:\n\n* Any type of arrhythmia, intraoperative need for other vasoactive drug intervention.'}, 'identificationModule': {'nctId': 'NCT03497351', 'briefTitle': 'Effects of Different Kinds of Hypotensive Drugs on Dynamic Hemodynamic Changing in Patients Under Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Effects of Different Kinds of Antihypertensive Drugs on Dynamic Hemodynamic Changing of During Laparoscopic Gastrectomy and Laparotomy', 'orgStudyIdInfo': {'id': 'PLAGHAOC004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group N', 'description': 'the group treated with nicardipine', 'interventionNames': ['Drug: Nicardipine']}, {'type': 'EXPERIMENTAL', 'label': 'Group U', 'description': 'the group treated with Urapidil', 'interventionNames': ['Drug: Urapidil']}], 'interventions': [{'name': 'Nicardipine', 'type': 'DRUG', 'description': 'The patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Nicardipine was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again.', 'armGroupLabels': ['Group N']}, {'name': 'Urapidil', 'type': 'DRUG', 'description': 'The patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Urapidil was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again.', 'armGroupLabels': ['Group U']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Haidian', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor', 'investigatorFullName': 'Yi Liu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}