Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT03409835
Status:
UNKNOWN
Last Update Posted:
2018-04-20
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ramosetron on Post-discharge Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the occurrence of postoperative nausea', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour'}, {'measure': 'The change in the occurrence of postoperative vomiting', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour'}], 'secondaryOutcomes': [{'measure': 'The change of postoperative pain score', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour', 'description': 'Score range is from 0 to 10.'}, {'measure': 'The change in the number of postoperative administration of rescue analgesic drug', 'timeFrame': 'Postoperative 30 minute and 3 hour'}, {'measure': 'The change in the number of postoperative administration of rescue antiemetic drug', 'timeFrame': 'Postoperative 30 minute and 3 hour'}, {'measure': "The change of patient's satisfaction score", 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour', 'description': 'Score range is from 0 to 10.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hysteroscopy']}, 'descriptionModule': {'briefSummary': 'Nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists physical statue 3 or more\n* Planned admission after surgery\n* Intravenous anesthesia\n* During chemotherapy\n* Pregnancy or breastfeeding\n* Abnormal liver or kidney function'}, 'identificationModule': {'nctId': 'NCT03409835', 'briefTitle': 'Effect of Ramosetron on Post-discharge Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Effect of Ramosetron on Post-discharge Nausea and Vomiting in Patients Undergoing Gynecologic Surgery Through a Day-surgery Center', 'orgStudyIdInfo': {'id': 'PDNV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramosetron', 'interventionNames': ['Drug: Ramosetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Ramosetron', 'type': 'DRUG', 'description': 'Ramosetron 0.3 mg is administered after induction of general anesthesia.', 'armGroupLabels': ['Ramosetron']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline 2 ml is administered after induction of general anesthesia.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Seok Na', 'role': 'CONTACT', 'email': 'hsknana@gmail.com', 'phone': '1087012913'}], 'facility': 'Seoul National Univ. Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Hyo-Seok Na', 'role': 'CONTACT', 'email': 'hsknana@gmail.com', 'phone': '1087012913'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}