Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-04 @ 7:01 AM
Study NCT ID:
NCT05326360
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2022-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ramosetron on Late PONV (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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of PONV', 'timeFrame': '24hour postoperatively', 'description': 'number of nausea, vomiting, retching'}], 'secondaryOutcomes': [{'measure': 'number of PONV', 'timeFrame': '1hour, 6hour, 48 hour postoperatively', 'description': 'number of nausea, vomiting, retching'}, {'measure': 'Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score', 'timeFrame': '1hour, 6hour, 24hour, 48 hour postoperatively', 'description': 'further detaied quantified in PONV experience, total score: 32, none:0, mild: 1-8 point, moderate: 9-16 point, great: 17-24 point, severe: 25-32 point'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mastectomy', 'postoperative nausea and vomiting', 'ramosetron'], 'conditions': ['Postoperative Nausea and Vomiting', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.', 'detailedDescription': "The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods.\n\nIntravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age over 18 years\n* American Society of Anesthesiologists (ASA) physical status I or II\n* requesting IV PCA (patient control of analgesia) for pain control\n* the high-risk group of PONV with a score of 3 or more as measured by the Apfel's score.\n\nExclusion Criteria:\n\n* emergency operation\n* re-operation\n* drug abuse, allergy\n* major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease)\n* smoker\n* pregnancy\n* lactation\n* previously use of antiemetics or systemic steroids within 48 before surgery"}, 'identificationModule': {'nctId': 'NCT05326360', 'briefTitle': 'Ramosetron on Late PONV (Postoperative Nausea and Vomiting)', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Hospital'}, 'officialTitle': 'The Effect of Additional Administration of Ramosetron on Late PONV (Postoperative Nausea and Vomiting) in Patients Undergoing Breast Surgery', 'orgStudyIdInfo': {'id': '2012-001-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'group C', 'description': 'receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron'}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points', 'interventionNames': ['Drug: Ramosetron Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'group M', 'description': 'receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen', 'interventionNames': ['Drug: Ramosetron Hydrochloride']}], 'interventions': [{'name': 'Ramosetron Hydrochloride', 'type': 'DRUG', 'description': 'we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.', 'armGroupLabels': ['group B', 'group M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hopsital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eunsoo Kim', 'investigatorAffiliation': 'Pusan National University Hospital'}}}}