Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT01169805
Status:
COMPLETED
Last Update Posted:
2011-11-18
First Post:
2010-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'C071315', 'term': 'ramosetron'}, {'id': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D007546', 'term': 'Isoquinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-16', 'studyFirstSubmitDate': '2010-07-22', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of nausea', 'timeFrame': 'during 73 hours after surgery'}, {'measure': 'the number of vomiting', 'timeFrame': 'during 73 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Laparoscopic Marsupialization of Renal Cyst']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective randomized controlled study was to compare the prophylactic effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on PCA-related nausea and vomiting after urologic laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II\n* Patients aged (20-65 yr) Undergoing Laparoscopic Nephrectomy\n* Patients who want a patient-controlled IV analgesia (IV-PCA)\n\nExclusion Criteria:\n\n* History of allergy or hypersensitivity to 5-HT3 antagonist\n* History of severe postoperative nausea/vomiting\n* Prolonged QT interval on preoperative EKG\n* Hypokalemia, Hypomagnesemia\n* Intestinal obstruction\n* Pregnant female or breast feeding mother'}, 'identificationModule': {'nctId': 'NCT01169805', 'briefTitle': 'Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery', 'orgStudyIdInfo': {'id': '4-2010-0176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONSERAN', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'EXPERIMENTAL', 'label': 'NASEA', 'interventionNames': ['Drug: Ramosetron']}, {'type': 'EXPERIMENTAL', 'label': 'ALOXI', 'interventionNames': ['Drug: Palonosetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'interventionNames': ['Drug: Normal saline inj']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['ONSERAN'], 'description': 'Ondansetron/single injection/4 mg/IV', 'armGroupLabels': ['ONSERAN']}, {'name': 'Ramosetron', 'type': 'DRUG', 'otherNames': ['NASEA'], 'description': 'Ramosetron HCl/single injection/0.3mg/IV', 'armGroupLabels': ['NASEA']}, {'name': 'Palonosetron', 'type': 'DRUG', 'otherNames': ['ALOXI'], 'description': 'Palonosetron HCl/single injection/0.075mg/IV', 'armGroupLabels': ['ALOXI']}, {'name': 'Normal saline inj', 'type': 'DRUG', 'description': 'normal saline injection 2ml', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hae Keum Kil', 'investigatorAffiliation': 'Yonsei University'}}}}