Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-29 @ 6:07 PM
Study NCT ID:
NCT01482468
Status:
UNKNOWN
Last Update Posted:
2012-03-23
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-21', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': '24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'severity of nausea', 'timeFrame': 'for 24 hours after sugery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Physical Status 1 or 2\n* Elective gynaecological laparoscopic surgery of ≥ 1h duration\n\nExclusion Criteria:\n\n* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation\n* Vomiting or retching in the 24 h preceding surgery\n* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry\n* Ongoing vomiting from gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT01482468', 'briefTitle': 'Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': "Incheon St.Mary's Hospital"}, 'officialTitle': 'Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting', 'orgStudyIdInfo': {'id': 'OC11MISI0109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continuous infusion', 'description': 'continuous infusion of palonosetron added to prophylactic single injection of palonosetron', 'interventionNames': ['Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'singel injection', 'description': 'continuous infusion of normal saline added to prophylactic single injection of palonosetron', 'interventionNames': ['Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron']}], 'interventions': [{'name': 'continuous infusion of palonosetron added to prophylactic single injection of palonosetron', 'type': 'DRUG', 'description': 'continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg', 'armGroupLabels': ['continuous infusion']}, {'name': 'continuous infusion of normal saline added to prophylactic single injection of palonosetron', 'type': 'DRUG', 'description': 'continuous infusion of normal saline after single injection of palonosetron 0.075mg', 'armGroupLabels': ['singel injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403-720', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo Kyoung Park', 'role': 'CONTACT', 'email': 'hardmong@korea.com', 'phone': '82-32-280-5410'}], 'facility': "Incheon St Mary's hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Soo Kyoung Park', 'role': 'CONTACT', 'email': 'hardmong@korea.com', 'phone': '82-32-280-5410'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Incheon St.Mary's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clnical professor', 'investigatorFullName': 'Soo Kyoung Park', 'investigatorAffiliation': "Incheon St.Mary's Hospital"}}}}