Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
Study NCT ID:
NCT06151457
Status:
UNKNOWN
Last Update Posted:
2023-11-30
First Post:
2023-11-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
90% Effective Dose of Norepinephrine Infusions Under Intensive and Standard Treatment in Preeclamptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}], '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'}]}}, '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': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, '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': '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 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard 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 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard 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': 'NCT06151457', 'briefTitle': '90% Effective Dose of Norepinephrine Infusions Under Intensive and Standard Treatment in Preeclamptic Patients', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': '90% Effective Dose of Norepinephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment in Preeclamptic Patients During Cesarean Section', 'orgStudyIdInfo': {'id': 'Yi Chen-2024-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard group', 'description': 'The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.', 'interventionNames': ['Drug: Alpha-Agonist']}, {'type': 'OTHER', 'label': 'Intensive 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: α-adrenergic receptor agonist']}], 'interventions': [{'name': 'Alpha-Agonist', 'type': 'DRUG', 'otherNames': ['Norepinephrine'], 'description': 'An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Standard group']}, {'name': 'α-adrenergic receptor agonist', 'type': 'DRUG', 'otherNames': ['Norepinephrine'], 'description': 'An initial infusion dose of prophylactic norepinephrine (0.05 ug/kg/min) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 0.01 ug/kg/min of prophylactic norepinephrine according to the responses of previous patients according to the up-down sequential allocation.', 'armGroupLabels': ['Intensive 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'}}}}