Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 4:53 PM
Study NCT ID:
NCT05248932
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norepinephrine to Prevent Hypotension in Ceasrean Delivery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'throracic volume variations change from baseline', 'timeFrame': 'every 10 minutes up to 1 hour', 'description': 'using cardiometry'}, {'measure': 'cardiac index change from baseline', 'timeFrame': 'every 10 minutes up to 1 hour', 'description': 'using cardiometry'}, {'measure': 'systemic vascular resistance change from baseline', 'timeFrame': 'every 10 minutes up to 1 hour', 'description': 'using cardiometry'}, {'measure': 'stroke volume variation change from baseline', 'timeFrame': 'every 10 minutes and up to 1 hour', 'description': 'using cardiometry'}], 'secondaryOutcomes': [{'measure': 'umblical cord gases sample', 'timeFrame': 'in the first minute after delivery'}, {'measure': 'APGAR score', 'timeFrame': 'after 5 minutes and 10 minutes after delivery', 'description': 'score from 1 to 10 with the highest score better for neonatal outcome'}, {'measure': 'Non invasive MEAN blood pressure', 'timeFrame': 'every 10 minutes and up tp 1 hour', 'description': 'change from baseline'}, {'measure': 'Heart rate', 'timeFrame': 'every 10 minutes and up to 1 hour', 'description': 'change from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypotension', 'norepinephrine'], 'conditions': ['Hypotension', 'Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.', 'detailedDescription': 'Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee.\n\nAll subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile.\n\nStandardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection.\n\n10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr.\n\nPatients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.\n\nThe patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I \\& II\n* Non laboring\n* Normotensive\n* Elective cesarean delivery under spinal anesthesia.\n* Baseline systolic blood pressure 90-140 mm Hg\n\nExclusion Criteria:\n\n* Known fetal abnormality.\n* Preexisting or pregnancy-induced hypertension.\n* Known cardiovascular or cerebrovascular disease.\n* Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.\n* Weight \\<50 or \\>100 kg, height \\<140 or \\>180 cm.\n* Inability or refusal to give informed consent'}, 'identificationModule': {'nctId': 'NCT05248932', 'briefTitle': 'Norepinephrine to Prevent Hypotension in Ceasrean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.', 'orgStudyIdInfo': {'id': '19919ANET33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'infusion', 'description': 'patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline', 'interventionNames': ['Device: cardiometry', 'Drug: Norepinephrine infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bolus', 'description': 'patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to \\<80% of the baseline value.', 'interventionNames': ['Drug: Norepinephrine bolus', 'Device: cardiometry']}], 'interventions': [{'name': 'Norepinephrine bolus', 'type': 'DRUG', 'description': '5 microgram bolus therapy', 'armGroupLabels': ['bolus']}, {'name': 'cardiometry', 'type': 'DEVICE', 'description': 'cardiac output, stroke volume and fluid responsiveness monitoring', 'armGroupLabels': ['bolus', 'infusion']}, {'name': 'Norepinephrine infusion', 'type': 'DRUG', 'description': '2.5 microgram/min infusion', 'armGroupLabels': ['infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'country': 'Egypt', 'facility': 'Faculty of Medicine, University Hospitals', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'mostafa saieed fahim mansour', 'investigatorAffiliation': 'Menoufia University'}}}}