Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT05078606
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2021-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059168', 'term': 'Carotid Intima-Media Thickness'}, {'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000092262', 'term': 'Ultrasonography, Carotid Arteries'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of IJV collapsibility index as predictor of Spinal anesthesia induced hypotension.', 'timeFrame': '10 minutes', 'description': '(Area under receiver operating characteristic curves)'}], 'secondaryOutcomes': [{'measure': 'Accuracy of rate of change in IJV area with change in posture as a predictor of Spinal anesthesia induced hypotension.', 'timeFrame': '10 minutes', 'description': '(Area under receiver operating characteristic curves)'}, {'measure': 'Incidence of Spinal anesthesia induced hypotension', 'timeFrame': '20 minutes', 'description': 'Change in mean arterial blood pressure 25% less than the preoperative baseline level.'}, {'measure': 'Carotid intima media thickness.', 'timeFrame': '10 minutes', 'description': 'IMT is measured as the distance between lumen-intima and media-adventitia interfaces'}, {'measure': 'Norepinephrine consumption', 'timeFrame': '20 minutes', 'description': 'the total dose of norepiniphrine and number of boluses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-spinal Hypotension']}, 'referencesModule': {'references': [{'pmid': '31572075', 'type': 'BACKGROUND', 'citation': 'Singh Y, Anand RK, Gupta S, Chowdhury SR, Maitra S, Baidya DK, Singh AK. Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):312-317. doi: 10.4103/sja.SJA_27_19.'}, {'pmid': '31580292', 'type': 'BACKGROUND', 'citation': 'Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study: erratum. Eur J Anaesthesiol. 2019 Nov;36(11):888. doi: 10.1097/EJA.0000000000001094. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Spinal anesthesia induces sympathetic blockade and venodilation, thus reducing venous return and the cardiac output. Therefore, assessment of intravascular volume deficit before anesthesia might predict a critical decrease in blood pressure after anesthesia.\n\nRecently, ultrasonographic evaluation of the internal jugular vein (IJV) has been used to reflect intravascular volume status and fluid and as a predictor of hypotension after induction of general anesthesia.\n\nCarotid intima-media thickness (CIMT) has been used to predict atherosclerosis-related events, such as stroke, myocardial infarction, peripheral artery disease, and hypotension after induction of anesthesia with a cut-off value of 0.65 mm of CIMT as a threshold level.', 'detailedDescription': 'This study aims to evaluate the ability of preoperative Ultrasonographic assessment of the internal jugular vein (IJV) and Carotid intima-media thickness (CIMT) to predict spinal anesthesia induced hypotension (SAIH).\n\nParticipants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>60 years)\n* ASA I-II-III\n* Patients scheduled for elective surgeries under spinal anesthesia.\n\nExclusion Criteria:\n\n* Operations which will last for less than 15 minutes.\n* Deep vein thrombosis in the upper extremities.\n* History of radiotherapy or neck surgery.\n* Previous sonographic data show tricuspid or mitral regurgitation or a very distended right atrium and ventricle.\n* Patients with history of valvular or carotid artery surgery, arrhythmia, heart failure.\n* Being unable to lie in a supine position for the necessary measurements.\n* Technical limitations to imaging of the IJV and carotid artery.'}, 'identificationModule': {'nctId': 'NCT05078606', 'briefTitle': 'Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Pre-anesthetic Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly: a Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'MD-152-2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IJV Ultrasonography', 'type': 'DEVICE', 'description': 'Patient will be in supine position, The linear probe with frequency of 7- 12 M hz; depth of 3 cm. maximum IJV diameter (IJV-D) and area (IJV-A) will be recorded. M-mode will be used to obtain the distance between the 2 walls of the vein during inspiration and expiration.\n\nThen, the patient will be positioned 10° Trendelenburg and similar ultrasonographic measurements will be again performed'}, {'name': 'Carotid Intima Media Thickness', 'type': 'DEVICE', 'description': 'US Probe is slided superiorly (toward the head) or inferiorly (toward the feet) until the bifurcation of the common carotid artery (CCA) appears on the left side of the screen. This is the ideal location for imaging and CIMT measurements.\n\nIMT is assessed in longitudinal view from the arterial far wall, along a 10mm length. CIMT will appear as two parallel lines (leading edges of two anatomical boundaries) from it: lumen- intima and media- adventitia interfaces perpendicular to ultrasound beams.'}, {'name': 'Spinal anesthesia', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be performed in the sitting position at level of L3-4 or L4- 5 interspaces with a 25-gauge spinal needle. Local infiltration of skin and subcutaneous tissue with 2% lignocaine will be applied. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T8 dermatomal level block.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Bassant abdelhamid', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Bassant M. Abdelhamid', 'investigatorAffiliation': 'Cairo University'}}}}