Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03195166
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2017-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'consecutive patient'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients. An oral intake of 250 ml of water was taken 2 hours before surgery.\n\nRadial arterial catheter was putted under local anesthesia and connected to the FloTrac sensor/Vigileo haemodynamic monitoring system.\n\nFluid therapy was limited to 4 ml/kg/h until tourniquet release.\n\nSubarachnoid puncture was performed at the L3-S1 interspace. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.\n\nEphedrine 6 to 9 mg was given if systolic arterial pressure \\< 90 mmHg. Investigators measured blood pressure (systolic, diastolic and mean), stroke volume and cardiac output every 5 minutes from beginning of the operation and until 2 hours after the end.\n\nNumber of hypotension episodes and ephedrine consumption were noted.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2017-06-04', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemodynamic profile during continuous spinal anesthesia in elderly', 'timeFrame': 'Day 0', 'description': 'cardiac output , L/min'}], 'secondaryOutcomes': [{'measure': 'blood pressure variation', 'timeFrame': 'Day 0', 'description': 'systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg'}, {'measure': 'ephedrine use', 'timeFrame': 'Day 0', 'description': 'ephedrine consumption , mg'}, {'measure': 'stoke volume modification', 'timeFrame': 'Day 0', 'description': 'stroke volume, L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elderly spinal anesthesia'], 'conditions': ['Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients.\n\nThe aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients undergoing knee arthroplasty.\n\nInvestigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess modification blood pressure, stroke volume and cardiac output during anesthesia and specialy after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it off.\n\nthey recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours after the end of surgery.', 'detailedDescription': 'The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia (CSA) in elderly patients undergoing knee arthroplasty.\n\nInclusion criteria:\n\nAdult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia.\n\nStudy Design :\n\nPatients had a transthoracic echocardiography one to three months before the surgical procedure, performed by a cardiologist.\n\nAn oral intake of 250 ml of water was taken 2 hours before surgery. In the operating room, patients received monitoring with electrocardiogram, pulse oximetry and had their blood pressure measured and recorded via an indwelling radial arterial catheter putting under local anesthesia.\n\nThis catheter was connected to the FloTrac sensor/Vigileo haemodynamic monitoring systeme to track continuously stroke volume and cardiac output.\n\nAll patients were given nasal oxygen during all the procedure to keep oxygen saturation \\> 95 %. Fluid therapy was limited to 4 ml/kg/h until tourniquet release.\n\nSubarachnoid puncture was performed with a 19-Gauge Tuohy needle at the L3-S1 interspace using a midline approach. Three cm of a 22-Gauge catheter was introduced through the needle. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected through the catheter. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.\n\nEphedrine 6 to 9 mg was given if systolic arterial pressure \\< 90 mmHg or \\< 100 mmHg with clinical signs of poor tolerance (dizziness, anxiety, dyspnea, vomiting).\n\nSample size We included 20 patients in this observational study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, aged more than 65 years\n* scheduled for elective total knee arthroplasty\n* under regional anesthesia\n\nExclusion Criteria:\n\n* contraindication to regional anesthesia\n* or the patients who refused to give consent,\n* patients with anemia (hemoglobin \\< 13 g/dl for male and hemoglobin \\< 12 g/dl for female),\n* cardiac arrhythmias,\n* NYHA score \\> 2,\n* ASA \\> 2\n* Cardiac ejection fraction \\< 50 %,\n* valvulopathy,\n* pulmonary artery hypertension\n* and relaxation abnormality'}, 'identificationModule': {'nctId': 'NCT03195166', 'briefTitle': 'Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '101/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hemodynamic profile', 'description': 'FloTrac sensor/Vigileo', 'interventionNames': ['Diagnostic Test: FloTrac sensor/Vigileo']}], 'interventions': [{'name': 'FloTrac sensor/Vigileo', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia', 'armGroupLabels': ['hemodynamic profile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Tunis', 'state': 'La Manouba', 'country': 'Tunisia', 'facility': 'Kassab orthopedic Institute', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'KAABACHI OLFA, PROF', 'role': 'STUDY_CHAIR', 'affiliation': 'KASSAB ORTHOPEDIC INSTITUTE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Olfa kaabachi, MD', 'investigatorAffiliation': 'University Tunis El Manar'}}}}