Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-25 @ 8:46 PM
Study NCT ID:
NCT01669135
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2012-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min)', 'timeFrame': '5, 10, 50 min after spinal, 1 minute after delivery', 'description': 'Hemodynamic changes (changes in Blood Pressure and Heart rate) may reflect blood redistribution due to spinal block'}], 'primaryOutcomes': [{'measure': 'cerebral oxygen saturation of the right frontal lobe', 'timeFrame': 'Change from the performing of spinal anesthesia untill 1 minute after delivery', 'description': "Cerebral oxygen saturation is important as it may affect patient's outcome"}], 'secondaryOutcomes': [{'measure': 'cerebral oxygen saturation of the left frontal lobe', 'timeFrame': '5, 10, 50 min after spinal,1 minute after delivery', 'description': "Cerebral oxygen saturation is important for patient's outcome"}, {'measure': 'Thigh oxygen saturation', 'timeFrame': '5, 10, 50 min after spinal, 1 minute after delivery', 'description': 'Thigh oxygen saturation may reflect blood redistribution due to spinal block'}, {'measure': 'Arterial Oxygenation', 'timeFrame': '5, 10, 50 min after spinal, 1 minute after delivery', 'description': 'Changes in arterial oxygenation may reflect blood redistribution due to spinal block'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral oximetry', 'cesarean delivery'], 'conditions': ['Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery']}, 'referencesModule': {'references': [{'pmid': '24106922', 'type': 'DERIVED', 'citation': 'Fassoulaki A, Paraskeva A, Tsaroucha A. Cesarean delivery under spinal anesthesia is associated with decreases in cerebral oxygen saturation as assessed by NIRS: an observational study. Curr Med Res Opin. 2014 Mar;30(3):331-7. doi: 10.1185/03007995.2013.852526. Epub 2013 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term healthy parturients\n\nExclusion Criteria:\n\n* Body Mass Index \\> 35\n* preeclampsia\n* neurological,cardiovascular, respiratory disease'}, 'identificationModule': {'nctId': 'NCT01669135', 'briefTitle': 'Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'orgStudyIdInfo': {'id': 'M19-12-21-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Spinal Anesthesia with cerebral oxygen saturation monitoring', 'description': 'The cerebral oxygen saturation of the right and left frontal lobe as well as the thigh oxygen saturation are monitored during spinal anesthesia by means of the near-infrared spectroscopy. Hemodynamic variables were recorded at the same time points.', 'interventionNames': ['Other: Spinal Anesthesia with cerebral oxygen saturation monitoring']}], 'interventions': [{'name': 'Spinal Anesthesia with cerebral oxygen saturation monitoring', 'type': 'OTHER', 'otherNames': ['INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)'], 'armGroupLabels': ['Spinal Anesthesia with cerebral oxygen saturation monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Department of Anesthesiology, Aretaieio Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, DEAA', 'investigatorFullName': 'Argyro Fassoulaki', 'investigatorAffiliation': 'University of Athens'}}}}