Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-26 @ 3:22 PM
Study NCT ID:
NCT01147757
Status:
UNKNOWN
Last Update Posted:
2011-12-06
First Post:
2010-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-05', 'studyFirstSubmitDate': '2010-06-17', 'studyFirstSubmitQcDate': '2010-06-18', 'lastUpdatePostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fentanyl consumption for IV-PCA', 'timeFrame': '24 h and 48 h after surgery'}, {'measure': 'Postoperative pain score', 'timeFrame': 'during 48 h after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric patients (ASA physical status I or II) aged between'], 'conditions': ['Pediatrics']}, 'descriptionModule': {'briefSummary': 'Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy\n\nExclusion Criteria:\n\n* cardiovascular, renal, liver disease or growth retardation'}, 'identificationModule': {'nctId': 'NCT01147757', 'briefTitle': 'Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2010-0129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'Group S (n = 15): saline', 'interventionNames': ['Drug: remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'remifentanil 0.3 mcg/kg/min', 'description': 'Group 0.3 (n = 15): remifentanil 0.3 mcg/kg/min', 'interventionNames': ['Drug: remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'remifentanil 0.6 mcg/kg/min', 'description': 'Group 0.6 (n = 15): remifentanil 0.6 mcg/kg/min', 'interventionNames': ['Drug: remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'remifentanil 0.9 mcg/kg/min', 'description': 'Group 0.9 (n = 15): remifentanil 0.9 mcg/kg/min', 'interventionNames': ['Drug: remifentanil']}], 'interventions': [{'name': 'remifentanil', 'type': 'DRUG', 'description': 'During surgery, 3 different dose of remifentanil or placebo was infused.', 'armGroupLabels': ['remifentanil 0.3 mcg/kg/min', 'remifentanil 0.6 mcg/kg/min', 'remifentanil 0.9 mcg/kg/min', 'saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeong-Yeon Hong, M.D.', 'role': 'CONTACT', 'phone': '82-2-2228-2427'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jeong-Yeon Hong', 'role': 'CONTACT', 'email': 'jenyhongg@hanmail.net'}], 'overallOfficials': [{'name': 'Jeong-Yeon Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Jeong-Yeon Hong', 'investigatorAffiliation': 'Yonsei University'}}}}