Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-31 @ 7:44 PM
Study NCT ID:
NCT01238718
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2010-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Lidocaine in Rapid Sequence Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-04-24', 'releaseDate': '2012-03-30'}, {'resetDate': '2012-06-11', 'releaseDate': '2012-05-11'}, {'resetDate': '2012-07-18', 'releaseDate': '2012-06-14'}, {'resetDate': '2013-02-22', 'releaseDate': '2013-01-21'}, {'resetDate': '2019-02-18', 'releaseDate': '2018-10-09'}, {'resetDate': '2019-05-30', 'releaseDate': '2019-02-18'}], 'estimatedResultsFirstSubmitDate': '2012-03-30'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BIS changes after lidocaine administration in rapid sequence induction', 'timeFrame': 'change from baseline in BIS values during 10 minutes'}], 'secondaryOutcomes': [{'measure': 'change in blood pressure', 'timeFrame': 'change from baseline in blood pressure during 10 minutes'}, {'measure': 'change in Heart rate', 'timeFrame': 'change from baseline in heart rate durng 10 minutes'}]}, 'conditionsModule': {'keywords': ['lidocaine', 'anesthetic depth', 'hemodynamics', 'rapid sequence induction', 'BIS'], 'conditions': ['Hemodynamic Response']}, 'descriptionModule': {'briefSummary': 'Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reason for rapid sequence induction (emergency, reflux),\n* ASA I-II,\n* no antihypertensive drugs,\n* no antiarrhythmic drugs\n\nExclusion Criteria :'}, 'identificationModule': {'nctId': 'NCT01238718', 'briefTitle': 'Use of Lidocaine in Rapid Sequence Induction', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction', 'orgStudyIdInfo': {'id': 'lidocaine3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'lidocaine 1.5 mg/kg intravenously', 'armGroupLabels': ['lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'normal saline', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Aretaieio Hospital, University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'University of Athens', 'oldOrganization': 'Chryssoula Staikou, 1st department of Anesthesiology, Aretaieio Hospital, University of Athens, Greece'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-03-30', 'type': 'RELEASE'}, {'date': '2012-04-24', 'type': 'RESET'}, {'date': '2012-05-11', 'type': 'RELEASE'}, {'date': '2012-06-11', 'type': 'RESET'}, {'date': '2012-06-14', 'type': 'RELEASE'}, {'date': '2012-07-18', 'type': 'RESET'}, {'date': '2013-01-21', 'type': 'RELEASE'}, {'date': '2013-02-22', 'type': 'RESET'}, {'date': '2018-10-09', 'type': 'RELEASE'}, {'date': '2019-02-18', 'type': 'RESET'}, {'date': '2019-02-18', 'type': 'RELEASE'}, {'date': '2019-05-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Staikou Chryssoula, MD, DESA, Instructor in University of Athens, University of Athens'}}}}