Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:48 PM
Study NCT ID:
NCT00878228
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2009-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D017294', 'term': 'Ondansetron'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KimD@hss.edu', 'phone': '212-606-1206', 'title': 'Dr. David Kim', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Group', 'description': 'The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postdischarge Day 1', 'description': 'Percentage of participants with nausea', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postdischarge Day 1', 'description': 'Percentage of participants reporting moderate or severe nausea in the first 24 hours', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Impact of Nausea and Vomiting on Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postdischarge Day 1', 'description': 'Percentage of participants whose quality of life was impacted by nausea and vomiting', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group', 'description': 'The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group', 'description': 'The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '14', 'groupId': 'BG000'}, {'value': '37', 'spread': '11', 'groupId': 'BG001'}, {'value': '39', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '98 patients were enrolled in the study, but 22 were excluded for various reasons. The remaining 76 patients were analyzed for the study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '98 patients were enrolled in the study, but 22 were excluded for various reasons. The remaining 76 patients were analyzed for the study.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2009-04-07', 'resultsFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-23', 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Nausea', 'timeFrame': 'Postdischarge Day 1', 'description': 'Percentage of participants with nausea'}], 'secondaryOutcomes': [{'measure': 'Severity of Nausea', 'timeFrame': 'Postdischarge Day 1', 'description': 'Percentage of participants reporting moderate or severe nausea in the first 24 hours'}, {'measure': 'Impact of Nausea and Vomiting on Quality of Life', 'timeFrame': 'Postdischarge Day 1', 'description': 'Percentage of participants whose quality of life was impacted by nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nausea and Vomiting, Postoperative']}, 'referencesModule': {'references': [{'pmid': '9257427', 'type': 'BACKGROUND', 'citation': 'Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078.'}, {'pmid': '18633020', 'type': 'BACKGROUND', 'citation': 'Pan PH, Lee SC, Harris LC. Antiemetic prophylaxis for postdischarge nausea and vomiting and impact on functional quality of living during recovery in patients with high emetic risks: a prospective, randomized, double-blind comparison of two prophylactic antiemetic regimens. Anesth Analg. 2008 Aug;107(2):429-38. doi: 10.1213/ane.0b013e318172f992.'}, {'pmid': '18042859', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.'}, {'pmid': '15190136', 'type': 'BACKGROUND', 'citation': 'Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.'}, {'pmid': '18633023', 'type': 'BACKGROUND', 'citation': "White PF, O'Hara JF, Roberson CR, Wender RH, Candiotti KA; POST-OP Study Group. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008 Aug;107(2):452-8. doi: 10.1213/ane.0b013e31817b842c."}, {'pmid': '18633024', 'type': 'BACKGROUND', 'citation': 'White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63. doi: 10.1213/ane.0b013e31817aa6e4.'}, {'pmid': '12198050', 'type': 'BACKGROUND', 'citation': 'Pavlin DJ, Chen C, Penaloza DA, Polissar NL, Buckley FP. Pain as a factor complicating recovery and discharge after ambulatory surgery. Anesth Analg. 2002 Sep;95(3):627-34, table of contents. doi: 10.1097/00000539-200209000-00025.'}], 'seeAlsoLinks': [{'url': 'http://www.hss.edu', 'label': 'This is the link to the Hospital for Special Surgery home website.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery\n* Planned use of neuraxial anesthesia\n* Ability to follow study protocol\n* Willing to complete daily diary and be interviewed daily for three days after discharge\n\nExclusion Criteria:\n\n* Patients younger than 18 years old and older than 65\n* Patients unable to undergo a spinal or epidural anesthetic\n* Having nausea or vomiting within 24 hours of the surgery\n* Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan)\n* Chronic opioid use (defined as daily or almost daily use of opioids for \\>3 months)\n* Hypersensitivity and/or allergy to ondansetron\n* Intraoperative use of any volatile anesthetic\n* Contraindication to a short course of NSAIDs (renal failure, intolerance)\n* Allergy or intolerance to Vicodin'}, 'identificationModule': {'nctId': 'NCT00878228', 'acronym': 'PDNV', 'briefTitle': 'Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy', 'orgStudyIdInfo': {'id': '29015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos.', 'armGroupLabels': ['Study Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jacques YaDeau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hosptial for Special Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}