Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT03328533
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], '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': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-14', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post-spinal anesthesia hypotension.', 'timeFrame': '30 minutes after spinal anesthesia', 'description': 'Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading'}], 'secondaryOutcomes': [{'measure': 'Incidence of severe post-spinal anesthesia hypotension', 'timeFrame': '30 minutes after spinal anesthesia', 'description': 'Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading'}, {'measure': 'Incidence of severe delivery hypotension', 'timeFrame': '10 minutes after delivery', 'description': 'Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading'}, {'measure': 'Systolic blood pressure', 'timeFrame': '2 hours after subarachnoid block', 'description': 'Systolic blood pressure measured in mmHg'}, {'measure': 'Heart rate', 'timeFrame': '2 hours after subarachnoid block', 'description': 'number of heart beats per minute'}, {'measure': 'APGAR score for assessment of the general state of the fetus', 'timeFrame': '10 minutes after delivery', 'description': 'APGAR score of the fetus ranging from 0 to 10. the higher the value, the better he score'}, {'measure': 'Incidence of reactive hypertension', 'timeFrame': '2 hours after spinal anesthesia', 'description': 'Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading'}, {'measure': 'Umbilical arterial potential hydrogen (PH)', 'timeFrame': '10 minutes after delivery', 'description': 'PH in the blood sample obtained from umbilical artery scaled from 1 to 14'}, {'measure': 'Umbilical arterial Partial pressure of Carbon dioxide', 'timeFrame': '10 minutes after delivery', 'description': 'in the blood sample obtained from umbilical artery measured in mmHg'}, {'measure': 'incidence of nausea', 'timeFrame': '2 hours', 'description': 'The percentage of patients with nausea'}, {'measure': 'Incidence of vomiting', 'timeFrame': '2 hours', 'description': 'The percentage of patients with nausea'}, {'measure': 'Total phenylephrine consumption', 'timeFrame': '2 hours', 'description': 'the total dose of phenylephrine consumed during the operation'}, {'measure': 'Total norepinephrine consumption', 'timeFrame': '2 hours', 'description': 'the total dose of norepinephrine consumed during the operation'}, {'measure': 'Total ephedrine consumption', 'timeFrame': '2 hours', 'description': 'the total dose of ephedrine consumed during the operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications', 'Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery', 'detailedDescription': 'Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term\n* Pregnant women\n* Scheduled for cesarean section\n\nExclusion Criteria:\n\n* Pre-eclampsia\n* Eclampsia\n* Bleeding\n* Cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT03328533', 'briefTitle': 'Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial', 'orgStudyIdInfo': {'id': 'N-82-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phenylephrine', 'description': 'Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.', 'interventionNames': ['Drug: Phenylephrine', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Norepinephrine', 'description': 'Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.', 'interventionNames': ['Drug: Norepinephrine', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Phenylephrine', 'type': 'DRUG', 'description': 'Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.', 'armGroupLabels': ['Phenylephrine']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Levophed'], 'description': 'Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).', 'armGroupLabels': ['Norepinephrine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.', 'armGroupLabels': ['Norepinephrine', 'Phenylephrine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed M Mukhtar, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of research committee section in anesthesia department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Hasanin', 'investigatorAffiliation': 'Cairo University'}}}}