Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-30 @ 4:21 PM
Study NCT ID:
NCT03833895
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2019-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D000077331', 'term': "Ringer's Solution"}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2019-01-20', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring', 'timeFrame': 'through study completion, an average of 24 hour', 'description': 'Systolic blood pressure (SBP)'}, {'measure': 'Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring', 'timeFrame': 'Through study completion', 'description': 'Diastolic blood pressure (DBP)'}, {'measure': 'Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring', 'timeFrame': 'An average of 24 hour', 'description': 'Mean arterial pressure (MAP)'}, {'measure': 'Heart rate (HR) change as the one of hemodynamic outcome in general monitoring', 'timeFrame': 'Through the study completion, an average of 24 hour', 'description': 'Heart rate (HR)'}, {'measure': 'Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient', 'timeFrame': 'Through study completion, an average of 24 hour', 'description': 'Stroke volume (SV)'}, {'measure': 'Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient', 'timeFrame': 'Through study completion, an average of 24 hour', 'description': 'Cardiac output (CO)'}, {'measure': 'Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient', 'timeFrame': 'Through study completion, an average of 24 hour', 'description': 'Systemic vascular resistance (SVR)'}], 'secondaryOutcomes': [{'measure': 'The benefits to the fetus based on umbilical vein (UV) blood gas', 'timeFrame': 'Through study completion, an average of 24 hour', 'description': 'The umbilical vein (UV) blood gas'}, {'measure': 'The benefits to the fetus based on umbilical artery (UA) blood gas', 'timeFrame': 'Through study completion, an average of 24 hour', 'description': 'The umbilical artery (UA) blood gas'}, {'measure': 'The benefits to parturient based on peripheral vein (PV) blood gas', 'timeFrame': 'Through study completion, an average of 24 hour', 'description': 'Peripheral vein (PV) blood gas'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean delivery'], 'conditions': ['Cesarean Section Complications']}, 'referencesModule': {'references': [{'pmid': '32894044', 'type': 'DERIVED', 'citation': 'Feng K, Wang X, Feng X, Zhang J, Xiao W, Wang F, Zhou Q, Wang T. Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study. BMC Anesthesiol. 2020 Sep 7;20(1):229. doi: 10.1186/s12871-020-01145-0.'}]}, 'descriptionModule': {'briefSummary': 'Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and parturient during Cesarean Section', 'detailedDescription': '1. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring ( stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral vein (PV) blood gas during Cesarean Section.\n2. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under combined spinal-epidural anesthesia (CSEA),\n* American Society of Anesthesiologists (ASA) physical status I/II\n* 20 to 40 years old\n\nExclusion Criteria:\n\n* history of mental disorder or epilepsy,\n* tricyclic or imipramine antidepressant use,\n* central nervous system (CNS) disease,\n* preexisting or pregnancy-induced hypertension,\n* lumbar injury,\n* severe hypovolemia,\n* allergy\n* history of hypersensitivity to vasopressor\n* body mass index (BMI) \\>40 kg/m2,\n* infection at the puncture site'}, 'identificationModule': {'nctId': 'NCT03833895', 'briefTitle': 'The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'China International Neuroscience Institution'}, 'officialTitle': 'The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section', 'orgStudyIdInfo': {'id': 'CINI-AD-201812-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 Elements', 'description': 'Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 Elements', 'description': 'Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation', 'interventionNames': ['Drug: Phenylephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3 Elements', 'description': 'In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.', 'interventionNames': ["Drug: Ringer's Solution"]}], 'interventions': [{'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Group 1 Elements'], 'description': '0.05ug/kg/min Norepinephrine during Cesarean Section Operation', 'armGroupLabels': ['Group 1 Elements']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['Group 2 Elements'], 'description': '0.25ug/kg/min phenylephrine during Cesarean Section Operation', 'armGroupLabels': ['Group 2 Elements']}, {'name': "Ringer's Solution", 'type': 'DRUG', 'otherNames': ['Group 3 Elements'], 'description': '3 ml/kg/min of LR was administrated according to standard weight.', 'armGroupLabels': ['Group 3 Elements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Tianlong Wang, MD,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China International Neuroscience Institution', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}