Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06158035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment in Preeclamptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D014662', 'term': 'Vasoconstrictor Agents'}, {'id': 'D010656', 'term': 'Phenylephrine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-11-25', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ED50 and ED90', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'The doses of prophylactic norepinephrine and phenylephrine 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': 'Base excess', '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': 'APGAR score', 'timeFrame': '1 min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)'}, {'measure': 'APGAR score', 'timeFrame': '5 min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients 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. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during 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 ≥32 weeks\n* American Society of Anesthesiologists physical status classification I to III\n* Scheduled for cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Baseline blood pressure ≥160 mmHg\n* Body height \\< 150 cm\n* Body weight \\> 100 kg or body mass index (BMI) ≥ 40 kg/m2\n* Eclampsia or chronic hypertension\n* Hemoglobin \\< 7g/dl\n* Fetal distress, or known fetal developmental anomaly'}, 'identificationModule': {'nctId': 'NCT06158035', 'briefTitle': 'ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment in Preeclamptic Patients', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'ED90 of Norepinephrine and Phenylephrine Boluses for Treating Postspinal Anesthesia Hypotension Under Intensive Treatment in Preeclamptic Patients During Cesarean Section', 'orgStudyIdInfo': {'id': 'Yi Chen-2024-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norepinephrine group', 'description': 'The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Phenylephrine group', 'description': 'The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.', 'interventionNames': ['Drug: Phenylephrine']}], 'interventions': [{'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Vasopressor'], 'description': 'An initial infusion dose of prophylactic norepinephrine (6 ug) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 ug of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Norepinephrine group']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['Vasopressor'], 'description': 'An initial infusion dose of prophylactic phenylephrine (75 ug) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 12.5 ug of prophylactic phenylephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Phenylephrine group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yi Chen, M.D.', 'role': 'CONTACT', 'email': 'czzyxgp@163.com', 'phone': '86-951-674-3252'}], 'overallOfficials': [{'name': 'Yi Chen, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}