Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-25 @ 5:16 PM
Study NCT ID:
NCT03254303
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2017-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Cannulation In Children During Sevoflurane Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'particippant, investigator, outcomes assessor'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized and crossover assignemnt'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'laryngospasm', 'timeFrame': 'from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds', 'description': 'laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.'}], 'primaryOutcomes': [{'measure': 'Success of intravenous insertion', 'timeFrame': 'from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds', 'description': 'success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds'}], 'secondaryOutcomes': [{'measure': 'limb movement', 'timeFrame': 'from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds', 'description': 'The movement was classified using the scale:\n\n(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.\n\nThe movement was classified using the scale:\n\n(0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.\n\n• The movement was classified using the scale: (0 No movement, 1 movement)\n\n• The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sevoflurane, Catheterization, Anesthetics Inhalation, child'], 'conditions': ['Catheterization']}, 'referencesModule': {'references': [{'pmid': '9549737', 'type': 'BACKGROUND', 'citation': 'Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.'}, {'pmid': '15385009', 'type': 'RESULT', 'citation': 'Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.'}]}, 'descriptionModule': {'briefSummary': 'This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.', 'detailedDescription': "We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value \\<0.05 was considered significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with American Society of Anesthesiologist (ASA) physical status I or II\n* age between 1 and 12 years of either sex,\n* were scheduled for outpatient minor surgery under general anesthesia\n\nExclusion Criteria:\n\n* age \\<1 and \\>12 years\n* patients with full stomach\n* a history of gastric reflux\n* history of convulsions, cardiovascular or neuromuscular disease\n* suspected difficult airway and hyper-reactive airway disease'}, 'identificationModule': {'nctId': 'NCT03254303', 'briefTitle': 'Intravenous Cannulation In Children During Sevoflurane Induction', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate', 'orgStudyIdInfo': {'id': 'OMB: 0925-0586'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '60s (group E)', 'description': 'The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s', 'interventionNames': ['Other: Difficulty of catheterization in group 60 s']}, {'type': 'OTHER', 'label': '90s (groupe L)', 'description': 'In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s', 'interventionNames': ['Other: Difficulty of catheterization in group 90 s']}, {'type': 'OTHER', 'label': '120s (groupe L)', 'description': 'In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s', 'interventionNames': ['Other: Difficulty of catheterization in group 120 s']}], 'interventions': [{'name': 'Difficulty of catheterization in group 60 s', 'type': 'OTHER', 'armGroupLabels': ['60s (group E)']}, {'name': 'Difficulty of catheterization in group 90 s', 'type': 'OTHER', 'armGroupLabels': ['90s (groupe L)']}, {'name': 'Difficulty of catheterization in group 120 s', 'type': 'OTHER', 'armGroupLabels': ['120s (groupe L)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'leila Mansali Stambouli, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Fattouma Bourguiba Monastir TUNISIA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leila mansali stambouli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator and Clinical Professor', 'investigatorFullName': 'Leila mansali stambouli', 'investigatorAffiliation': 'University of Monastir'}}}}