Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 9:09 PM
Study NCT ID:
NCT06915493
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Glucose Levels in Children During Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Capillary blood sample glucose'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum blood glucose level', 'timeFrame': 'Immediately/within five minutes after anesthesia induction and prior to discontinuing the anesthesia administration.', 'description': 'Blood glucose sampling and measured during general anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatrics', 'Children', 'General anesthesia', 'Preoperative fasting', 'Fasting blood glucose', 'Hypoglycemia'], 'conditions': ['Fasting']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study aims to investigate blood glucose levels in children during general anesthesia and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting.\n\nBlood glucose will be measured following anesthesia induction and prior to discontinuing the administration of the anesthetic agent.', 'detailedDescription': 'This cross-sectional study aims to investigate blood glucose levels in children \\< 18 years during general anesthesia, and explore the incidence of hypoglycemia after anesthesia induction in relation to preoperative fasting.\n\nThe purpose is to evaluate whether guidelines for shortening the preoperative fasting period of children at our hospital have resulted in a shorter fasting duration and prevalence of low blood glucose levels during anesthesia induction. Also to shed light on blood glucose levels during general anesthesia and its correlation with intravenous fluid management and administration of steroidal anti-emetics.\n\nBlood glucose sampling will be obtained and measured following anesthesia induction and prior to discontinuing the anesthetic agent. If general anesthesia lasts longer than one hour, additional blood glucose analysis will be conducted one hour after the first measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample of children undergoing elective intervention under general anesthesia at Landspítali, the University Hospital of Iceland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren under 18 years of age who undergo intervention under general anesthesia. The parent or guardian understands and speaks Icelandic.\n\nExclusion Criteria:\n\nCoexisting disease or treatment that may affect fasting blood glucose level; Preoperative intravenous fluid administration; Beta-blockers; Insulin and corticosteroids, endocrine disorders, acute pain, and emergency interventions.'}, 'identificationModule': {'nctId': 'NCT06915493', 'briefTitle': 'Blood Glucose Levels in Children During Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Landspitali University Hospital'}, 'officialTitle': 'Blood Glucose Levels in Children During Anesthesia: Incidence of Hypoglycemia During Anesthesia Induction and Its Relationship to Preoperative Fasting', 'orgStudyIdInfo': {'id': '47/2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'General Anesthesia', 'type': 'OTHER', 'description': 'Blood glucose measurements during general anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '101', 'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'Anesthesia Department Landspitali UH', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}], 'overallOfficials': [{'name': 'Thorunn S Eliasdottir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Landspitali, the University Hospital of Iceland and University of Iceland'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'May 2025 - December 2026', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Landspitali University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Iceland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic chair, Associate Professor', 'investigatorFullName': 'Thorunn Scheving Eliasdottir', 'investigatorAffiliation': 'Landspitali University Hospital'}}}}