Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-07 @ 1:54 PM
Study NCT ID:
NCT02357693
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2015-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-09-27', 'releaseDate': '2018-01-29'}, {'resetDate': '2021-06-08', 'releaseDate': '2021-05-14'}, {'resetDate': '2022-03-04', 'releaseDate': '2021-12-17'}], 'estimatedResultsFirstSubmitDate': '2018-01-29'}}, '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': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2015-01-31', 'studyFirstSubmitQcDate': '2015-02-03', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of nausea and vomiting in postoperative period', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nausea, postoperative', 'postoperative nausea', 'postoperative vomiting', 'vomiting, postoperative'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '25220550', 'type': 'RESULT', 'citation': 'Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.', 'detailedDescription': 'High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high risk patients for nausea and vomiting\n\nExclusion Criteria:\n\n* cardiovascular disease, or hypersensibility to any of the drugs involved in the study'}, 'identificationModule': {'nctId': 'NCT02357693', 'acronym': 'PONV', 'briefTitle': 'Neurokinin Receptor Antagonist Associated to Ondansetron in PONV', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients', 'orgStudyIdInfo': {'id': 'CEP 280/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aprepitant', 'description': 'aprepitant 80 mg one hour before surgery', 'interventionNames': ['Drug: Aprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'oral placebo one hour before surgery', 'interventionNames': ['Drug: Aprepitant']}], 'interventions': [{'name': 'Aprepitant', 'type': 'DRUG', 'otherNames': ['Emend'], 'description': 'Aprepitant or placebo will be administered to the patient before surgery', 'armGroupLabels': ['aprepitant', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Angela Maria Sousa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Hazem a Ashmawi, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-01-29', 'type': 'RELEASE'}, {'date': '2018-09-27', 'type': 'RESET'}, {'date': '2021-05-14', 'type': 'RELEASE'}, {'date': '2021-06-08', 'type': 'RESET'}, {'date': '2021-12-17', 'type': 'RELEASE'}, {'date': '2022-03-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Instituto do Cancer do Estado de São Paulo'}}}}