Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-02 @ 3:53 PM
Study NCT ID:
NCT06513169
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that demonstrate hypotension', 'timeFrame': 'From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)', 'description': 'Hypotension is defined as the reduction in mean arterial pressure by 20% or greater comparing the blood pressure measured before induction of anesthesia'}], 'secondaryOutcomes': [{'measure': 'Number of participants that demonstrate Nadir blood pressure', 'timeFrame': 'From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)', 'description': 'Nadir blood pressure is the lowest value of blood pressure (BP) that can occur'}, {'measure': 'Change in heart rate', 'timeFrame': 'From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)'}, {'measure': 'Number of participants that need rescue vasoactive agents', 'timeFrame': 'From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)'}, {'measure': 'Accumulated dose of rescue vasoactive agents', 'timeFrame': 'End of study (within 15 minutes of baseline)'}, {'measure': 'Change in non-invasive cardiac output', 'timeFrame': 'From start of anesthesia upto institution of positive pressure ventilation (about 5 minutes)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypotension'], 'conditions': ['Post Induction Hypotension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if lower extremity elevation (LEE) will reduce the incidence of postinduction hypotension, to compare the utilization of vasoactive medications after induction in patients with LEE and patients without LEE and to determine if LEE will increase measured cardiac output'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA)3 or lower\n* Patients requiring general anesthesia\n\nExclusion Criteria:\n\n* Allergic reaction to drugs commonly used for general anesthesia including fentanyl, midazolam, propofol, ephedrine and phenylephrine\n* Pregnant women\n* Requiring rapid sequence induction\n* Prisoners\n* Patient refusal\n* Emergency Surgery'}, 'identificationModule': {'nctId': 'NCT06513169', 'briefTitle': 'Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Lower Extremity Elevation to Minimize Hemodynamic Instability During Induction of General Anesthesia - a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'HSC-MS-22-0145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: LEE', 'interventionNames': ['Procedure: Group 1: LEE']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2: no LEE'}], 'interventions': [{'name': 'Group 1: LEE', 'type': 'PROCEDURE', 'description': 'Patients will be in supine position during induction with a 12" wedge placed at the level of the Achilles tendon (LEE)', 'armGroupLabels': ['Group 1: LEE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ranganathan Govindaraj, MD', 'role': 'CONTACT', 'email': 'Ranganathan.Govindaraj@uth.tmc.edu', 'phone': '713-500-6200'}, {'name': 'Erikka Washington', 'role': 'CONTACT', 'email': 'Erikka.L.Washington@uth.tmc.edu', 'phone': '(713) 500-6202'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ranganathan Govindaraj, MD', 'role': 'CONTACT', 'email': 'Ranganathan.Govindaraj@uth.tmc.edu', 'phone': '(713) 500-6200'}, {'name': 'Erikka Washington', 'role': 'CONTACT', 'email': 'Erikka.L.Washington@uth.tmc.edu', 'phone': '(713) 500-6202'}], 'overallOfficials': [{'name': 'Ranganathan Govindaraj, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ranganathan Govindaraj', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}