Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-27 @ 10:34 AM
Study NCT ID:
NCT03851692
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2018-10-27
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': 'D004343', 'term': 'Drug Implants'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized single blinded parallel group controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2018-10-27', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement on iv placement', 'timeFrame': 'In the first 5 min after the anesthesic induction with sevoflurane', 'description': 'Number of children who presented movement on iv placement'}, {'measure': 'laryngospasm', 'timeFrame': 'Time From Intravenous Cannulation to patient extubation', 'description': 'The incidence of laryngospasm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sevoflurane', 'Intravenous Cannulation', 'anesthesia', 'child'], 'conditions': ['Intravenous Cannulation', 'Sevoflurane Induction', 'Child']}, 'referencesModule': {'references': [{'pmid': '29316032', 'type': 'BACKGROUND', 'citation': 'Hasan AK, Sivasankar R, Nair SG, Hasan WU, Latif Z. Optimum time for intravenous cannulation after induction with sevoflurane, oxygen, and nitrous oxide in children without any premedication. Paediatr Anaesth. 2018 Feb;28(2):179-183. doi: 10.1111/pan.13308. Epub 2018 Jan 8.'}, {'pmid': '29109638', 'type': 'BACKGROUND', 'citation': 'Kumar KR, Sinha R, Chandiran R, Pandey RK, Darlong V, Chandralekha. Evaluation of optimum time for intravenous cannulation after sevoflurane induction of anesthesia in different pediatric age groups. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):371-374. doi: 10.4103/joacp.JOACP_58_16.'}]}, 'descriptionModule': {'briefSummary': "The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). The aim of the investigator's study is to determine whether one should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia", 'detailedDescription': "the investigators 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* ASA I, II\n* Age from 1 to 12 years old\n* Ambulatory surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Age \\<1 year or\\> 12 years\n* non-ambulatory surgery,\n* contraindication for induction with sevoflurane'}, 'identificationModule': {'nctId': 'NCT03851692', 'briefTitle': 'Intravenous Cannulation In Children During Sevoflurane Induction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Fattouma Bourguiba'}, 'officialTitle': 'Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate', 'orgStudyIdInfo': {'id': '0925-0586'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '60s (group E)', 'description': 'Intravenous cannulation was released either 60 s following loss of lid reflex in group E', 'interventionNames': ['Other: Intravenous Cannulation (iv placement)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '90 or 120 s (groupe L)', 'description': 'Intravenous cannulation was released either 90 or 120 s following loss of lid reflex in group L', 'interventionNames': ['Other: Intravenous Cannulation (iv placement)']}], 'interventions': [{'name': 'Intravenous Cannulation (iv placement)', 'type': 'OTHER', 'description': 'The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.', 'armGroupLabels': ['60s (group E)', '90 or 120 s (groupe L)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Manel Ben Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Fattouma Bourguiba Monastir TUNISIA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Fattouma Bourguiba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ben ALI Manel', 'investigatorAffiliation': 'University Hospital Fattouma Bourguiba'}}}}