Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-29 @ 12:58 PM
Study NCT ID:
NCT06078228
Status:
UNKNOWN
Last Update Posted:
2024-08-05
First Post:
2023-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Hypotension During Induction of General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-31', 'releaseDate': '2024-08-14'}], 'estimatedResultsFirstSubmitDate': '2024-08-14'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-26', 'size': 593535, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-16T17:34', 'hasProtocol': True}, {'date': '2023-09-26', 'size': 412596, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-16T17:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the predictive value of the carotid Ftc for prediction of hypotension.', 'timeFrame': 'one year', 'description': 'to investigate the reliability of preanesthetic ultrasound measurements of the carotid artery FTc and the internal jugular vein collapsibility index in predicting hypotension during the induction of general anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Post induction hypotension is closely related to postoperative complications. Patients are at high risk of hypotension due to preexisting hypovolemia and the vasodilatory effects of induction agents. Ultrasonographic measurement of the Carotid artery corrected flow time and internal jugular vein collapsibility index may predict post induction hypotension.', 'detailedDescription': '* Type of Study: Observational Prospective Cohort Design.\n* Study Setting and ethical consideration: The approval of the Scientific Research Ethics Committee of the Faculty of Medicine, Ain Shams University will be obtained before starting work on the study. This study will be conducted in operating theatres of Ain Shams University Hospitals. Informed written consents to participate will be obtained from the patients.\n* Study Period: One year (October 2023-October 2024)\n* Study Population: Adult patient undergoing elective surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient undergoing elective surgeries.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- Patients of American Society of Anesthesiologists (ASA) physical status I to II of both genders.\n\n 2- Aged 18-65 years. 3- Elective surgeries under general anesthesia. 4- BMI less than 40.\n\nExclusion Criteria:\n\n* Patients with\n\n 1. Renal diseases.\n 2. Hepatic diseases.\n 3. ASA scores of 3-4.\n 4. The presence of a left ventricular ejection fraction less than 50%.\n 5. Age under 18 years old.\n 6. Patient refusal.\n 7. Coronary heart disease.\n 8. Cardiac disease including cardiomyopathy and mild to severe valve disease.\n 9. Pulmonary hypertension.\n 10. Peripheral arterial disease.\n 11. Preoperative cervical vascular ultrasound abnormalities including plaque, stenosis and anatomical variation.\n 12. Any previous neck surgery or trauma.'}, 'identificationModule': {'nctId': 'NCT06078228', 'briefTitle': 'Prediction of Hypotension During Induction of General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Assessment of Ultrasonographic Carotid Artery Corrected Flow Time and Internal Jugular Vein Collapsibility Index in Prediction of Hypotension During Induction of General Anesthesia', 'orgStudyIdInfo': {'id': 'FMASU MD205/2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Propofol - Fentanyl- Atracurium', 'type': 'DRUG', 'otherNames': ['Atropine'], 'description': 'investigate the reliability of preanesthetic ultrasound measurements of the carotid artery FTc and the internal jugular vein collapsibility index in predicting hypotension during the induction of general anesthesia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7154411', 'city': 'Cairo', 'state': 'Abbassia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Marina George, MD candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-14', 'type': 'RELEASE'}, {'date': '2024-10-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ain Shams University'}}}}