Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00926705
Status:
COMPLETED
Last Update Posted:
2009-06-23
First Post:
2009-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Infusion in Hypospadias Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-22', 'studyFirstSubmitDate': '2009-06-22', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative and postoperative fentanyl requirement (in microg/kg)', 'timeFrame': '6/2008-1/2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Fentanyl', 'Pain', 'Pediatrics'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '2900154', 'type': 'RESULT', 'citation': 'Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14. doi: 10.1016/0014-2999(88)90744-3.'}, {'pmid': '16803911', 'type': 'RESULT', 'citation': 'Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.'}, {'pmid': '14693611', 'type': 'RESULT', 'citation': 'Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-158. doi: 10.1213/01.ANE.0000093225.39866.75.'}, {'pmid': '15180019', 'type': 'RESULT', 'citation': 'Tobias JD, Berkenbosch JW. Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J. 2004 May;97(5):451-5. doi: 10.1097/00007611-200405000-00007.'}, {'pmid': '14693585', 'type': 'RESULT', 'citation': 'Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1-12 years undergoing hypospadias repair\n\nExclusion Criteria:\n\n* Allergy to Dexmedetomidine\n* Preoperative use of sedatives or analgesics\n* cardiac diseases\n* Children with mental retardation'}, 'identificationModule': {'nctId': 'NCT00926705', 'briefTitle': 'Dexmedetomidine Infusion in Hypospadias Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery', 'orgStudyIdInfo': {'id': 'alghanem2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl', 'description': 'This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine and Fentanyl', 'description': 'This group received a combination of Dexmedetomidine (1 ug/kg) and Fentanyl (1.79 ug/kg). Total number of patients in this group 24.', 'interventionNames': ['Drug: Dexmedetomidine and Fentanyl']}], 'interventions': [{'name': 'Dexmedetomidine and Fentanyl', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.', 'armGroupLabels': ['Dexmedetomidine and Fentanyl']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.', 'armGroupLabels': ['Fentanyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Khaled R Al-Zaben, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Jordan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'oldOrganization': 'University of Jordan'}}}}