Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07279805
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Perfusion Index as a Predictor of Post-spinal Hypotension in Patients Undergoing Lower Limb Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension spinal anesthesia-induced hypotension in patients undergoing lower limb surgeries', 'timeFrame': 'during the operation time.', 'description': 'Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Spinal Anaesthesia Hypotension']}, 'descriptionModule': {'briefSummary': 'This prospective observational study was carried out on a sample of 40 patients over a period of 6 months to asses the peripheral perfusion index as a Predictor for post spinal hypotension in patient undergoing lower limp surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing elective lower limb surgeries at El-demerdash Hospital of Surgery during the study period. Surgeries include Anterior/Posterior curciate ligament repair,knee arthroscopy,Hip and Knee replacement,tendon repair and varicose veins ligation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients aging between 21-40 years of both sexes with average weight of 60-80 kg, and average height of 160-180.\n\n * Patients undergoing Elective Lower limb Surgeries under successful spinal anesthesia (duration of surgery 45-120 minutes).\n * ASA physical status classes I - II.\n\nExclusion Criteria:\n\n* Patient's refusal of procedure or participation in the study.\n\n * ASA classes III or above. Coagulopathy and bleeding disorders.\n * Body mass index \\>40kg/m2\n * Contraindications to spinal anesthesia.\n * Hypersensitivity to the study medications.\n * Patients receiving vasoactive drugs.\n * Patients undergoing emergency surgery.\n * Duration more than 2hours.\n * Major bleeding."}, 'identificationModule': {'nctId': 'NCT07279805', 'briefTitle': 'Peripheral Perfusion Index as a Predictor of Post-spinal Hypotension in Patients Undergoing Lower Limb Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Peripheral Perfusion Index as a Predictor of Post-spinal Hypotension in Patients Undergoing Lower Limb Surgeries', 'orgStudyIdInfo': {'id': 'fmasu ms579/2024'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}