Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 11:58 PM
Study NCT ID:
NCT05690334
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}], 'ancestors': [{'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-18', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ED50 and ED90', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'The dose of prophylactic norepinephrine that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients'}], 'secondaryOutcomes': [{'measure': 'The incidence of post-spinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 80% of the baseline'}, {'measure': 'The incidence of severe post-spinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 60% of the baseline'}, {'measure': 'The incidence of bradycardia', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Heart rate \\< 60 beats/min'}, {'measure': 'The incidence of nausea and vomiting', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Presence of nausea and vomiting in patients after spinal anesthesia'}, {'measure': 'The incidence of hypertension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\>120% of the baseline'}, {'measure': 'pH', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical arterial blood gases'}, {'measure': 'Partial pressure of oxygen (PO2)', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical arterial blood gases'}, {'measure': 'Base excess (BE)', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical arterial blood gases'}, {'measure': 'APGAR score', 'timeFrame': '1 minute after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}, {'measure': 'APGAR score', 'timeFrame': '5 minute after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Norepinephrine', 'Postspinal anesthesia hypotension', 'Coload', 'Cesarean section'], 'conditions': ['Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of prophylactic norepinephrine infusions for preventing postspinal anesthesia hypotension during cesarean section.', 'detailedDescription': "Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. The purpose of this study is to investigate the effect of different crystalloid coload volumes on the 90% effective dose of norepinephrine infusion prophylaxis for hypotension during spinal anesthesia for cesarean section."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years\n* Primipara or multipara\n* Singleton pregnancy ≥37 weeks\n* American Society of Anesthesiologists physical status classification I to II\n* Scheduled for cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Body height \\< 150 cm\n* Body weight \\> 100 kg or body mass index (BMI) ≥ 40 kg/m2\n* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg\n* Hemoglobin \\< 7g/dl\n* Fetal distress, or known fetal developmental anomaly'}, 'identificationModule': {'nctId': 'NCT05690334', 'briefTitle': 'Different Crystalloid Coload Volumes on the 90% ED of Norepinephrine', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Up-and-Down Determination of Different Crystalloid Coload Volumes on the 90% Effective Dose of Prophylactic Norepinephrine Infusions for Preventing Postspinal Anesthesia Hypotension During Cesarean Section', 'orgStudyIdInfo': {'id': 'Yi Chen-2023-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'No fluid coload was given. An initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia', 'interventionNames': ['Drug: Crystalloid - 0 ml/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Crystalloid - 5 ml/kg', 'description': '5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.', 'interventionNames': ['Drug: Crystalloid - 5 ml/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Crystalloid - 10 ml/kg', 'description': '10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine simultaneous with spinal anesthesia.', 'interventionNames': ['Drug: Crystalloid - 10 ml/kg']}], 'interventions': [{'name': 'Crystalloid - 0 ml/kg', 'type': 'DRUG', 'otherNames': ['Crystalloid'], 'description': 'No fluid coload was given. An initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Control group']}, {'name': 'Crystalloid - 5 ml/kg', 'type': 'DRUG', 'otherNames': ['Crystalloid'], 'description': '5 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Crystalloid - 5 ml/kg']}, {'name': 'Crystalloid - 10 ml/kg', 'type': 'DRUG', 'otherNames': ['Crystalloid'], 'description': '10 ml/kg crystalloid coload combined with an initial infusion dose of prophylactic norepinephrine (0.025 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.005 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Crystalloid - 10 ml/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}], 'overallOfficials': [{'name': 'Yi Chen, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'General Hospital of Ningxia Medical University'}, {'name': 'Xiangsheng Xiong, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "The Fifth People's Hospital of Huaian"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}