Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-16 @ 1:27 AM
Study NCT ID:
NCT01013012
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2009-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-02', 'studyFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of postoperative nausea and vomiting(PONV)', 'timeFrame': 'After spinal surgery', 'description': 'incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['highly susceptible patients following spine surgery'], 'conditions': ['Nausea', 'Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females\n* Ages 18 to 65 years old\n\nExclusion Criteria:\n\n* Patients who is taking steroid or who had been treated for the gastrointestinal disease\n* Patients who have troubles with the kidney or liver\n* Patients transferring to the ICU after the surgery\n* overfat patients\n* Patients who had taken antiemetics within 24 hours before the surgery'}, 'identificationModule': {'nctId': 'NCT01013012', 'briefTitle': 'Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2007-0388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Group A : saline 1 ml + ramosetron 6μg/kg', 'interventionNames': ['Drug: ramosetron with saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B : dexamethasone 4 mg + ramosetron 6μg/kg', 'interventionNames': ['Drug: ramosetron with dexamethasone']}], 'interventions': [{'name': 'ramosetron with saline', 'type': 'DRUG', 'description': 'Group A : saline 1 ml, ramosetron 6μg/kg', 'armGroupLabels': ['Group A']}, {'name': 'ramosetron with dexamethasone', 'type': 'DRUG', 'description': 'Group B : dexamethasone 4 mg, ramosetron 6μg/kg', 'armGroupLabels': ['Group B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}