Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT04272567
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2020-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D014662', 'term': 'Vasoconstrictor Agents'}, {'id': 'D000077330', 'term': 'Saline 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': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'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', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of post-spinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Systolic blood pressure (SBP) \\< 80% of the baseline'}], 'secondaryOutcomes': [{'measure': 'Overall stability of systolic blood pressure control versus baseline', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Evaluated by performance error (PE).'}, {'measure': 'Overall stability of heart rate control versus baseline', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Evaluated by performance error (PE).'}, {'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 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 bradycardia.', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Heart rate \\< 55 beats/min.'}, {'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', 'timeFrame': 'Immediately after delivery.', 'description': 'From umbilical arterial blood gases.'}, {'measure': 'Base excess', 'timeFrame': 'Immediately after delivery.', 'description': 'From umbilical arterial blood gases.'}, {'measure': 'APGAR score', 'timeFrame': '1min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}, {'measure': 'APGAR score', 'timeFrame': '5min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Norepinephrine', 'Hypotension', 'Cesarean section', 'Dose-finding'], 'conditions': ['Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.', '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. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years\n* Primipara or multipara\n* Singleton pregnancy ≥37 weeks\n* American Society of Anesthesiologists physical status classification I to II\n* Scheduled for elective 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 ≥ 160mmHg\n* Hemoglobin \\< 7g/dl\n* Fetal distress, or known fetal developmental anomaly'}, 'identificationModule': {'nctId': 'NCT04272567', 'briefTitle': 'Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial', 'orgStudyIdInfo': {'id': 'Yi Chen-2020-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion', 'interventionNames': ['Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': '0.025 μg/kg/min group', 'description': 'Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'EXPERIMENTAL', 'label': '0.05 μg/kg/min group', 'description': 'Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'EXPERIMENTAL', 'label': '0.075 μg/kg/min group', 'description': 'Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'EXPERIMENTAL', 'label': '0.1 μg/kg/min group', 'description': 'Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).', 'interventionNames': ['Drug: Norepinephrine']}], 'interventions': [{'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Vasopressors'], 'description': 'Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.', 'armGroupLabels': ['0.025 μg/kg/min group', '0.05 μg/kg/min group', '0.075 μg/kg/min group', '0.1 μg/kg/min group']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['NS'], 'description': 'Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion', 'armGroupLabels': ['Control group']}]}, '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': 'Xinli Ni, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}