Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-01 @ 12:52 AM
Study NCT ID:
NCT02744495
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery
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': 'D001623', 'term': 'Betamethasone'}, {'id': 'D004329', 'term': 'Droperidol'}], 'ancestors': [{'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'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-13', 'studyFirstSubmitDate': '2016-04-08', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative nausea and vomiting', 'timeFrame': '48hour', 'description': 'postoperative nausea and vomiting as a categorical variable'}], 'secondaryOutcomes': [{'measure': 'number of postoperative nausea and vomiting', 'timeFrame': '48hour'}, {'measure': 'postoperative nausea and vomiting (VAS)', 'timeFrame': '48hour', 'description': 'Suffering from postoperative nausea and vomiting by visual assessment scale (VAS). VAS is a 100 point scale: 0 indicate absence of nausea or vomiting; 100 indicate maximal nausea and vomiting'}, {'measure': 'postoperative pain (VAS)', 'timeFrame': '48hour', 'description': 'VAS is a 100 point scale: 0 indicate absence of pain; 100 indicate maximal pain'}, {'measure': 'postoperative discomfort (VAS)', 'timeFrame': '48hour', 'description': 'VAS is a 100 point scale: 0 indicate absence of discomfort; 100 indicate maximal discomfort'}, {'measure': 'Antiemetics (treatment)', 'timeFrame': '48hour', 'description': 'Number of antiemetics used as a treatment for postoperative nausea or vomiting'}, {'measure': 'Analgesics', 'timeFrame': '48hour', 'description': 'Number of Analgesics used at 48h'}, {'measure': 'Side effects', 'timeFrame': '48hour'}, {'measure': 'QTc interval', 'timeFrame': '48hour', 'description': 'Pre and postoperative QTc (corrected) intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'corticoids', 'droperidol', 'antiemetics', 'Postoperative Vomiting', 'Postoperative Nausea', 'Postoperative Emesis', 'prophylaxis'], 'conditions': ['Postoperative Vomiting', 'Postoperative Nausea', 'Postoperative Emesis']}, 'descriptionModule': {'briefSummary': 'To investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. We designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors (if risk score is over 2) in the intervention arm.', 'detailedDescription': 'Patients planned to undergo cardiac surgery were screened for inclusion. Inclusion criteria are as follow: Non emergent cardiac surgery; Age \\> 18 years; Affiliation to French Social Security; Approval of participation to the study; at the exclusion of: Pregnancy ; Contra indication to antiemetics; Chronic usage of antiemetics; and Emergent or complicated surgery.\n\nRisk factors for postoperative nausea and vomiting were collected and patients were randomized by cluster into two arms.\n\nControl: No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors were not available for practicians.\n\nIntervention: Preoperative collection of postoperative nausea and vomiting risk factors available for practicians. Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.\n\nAll outcomes are assessed at 48 hours of surgery:\n\nPrimary: occurrence of postoperative nausea or vomiting Secondary: number of postoperative nausea and vomiting with visual assessment scale (VAS), and antiemetics used for treatment; postoperative pain (VAS) with number of analgesics used; postoperative discomfort (VAS).\n\nSafety data: side effects and QT corrected intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non emergent cardiac surgery\n* Age \\> 18 years\n* Affiliation to French Social Security\n* Approval of participation to the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Contra indication to antiemetics\n* Chronic usage of antiemetics\n* Emergent or complicated surgery'}, 'identificationModule': {'nctId': 'NCT02744495', 'acronym': 'PONVACS', 'briefTitle': 'Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Privé de Parly II - Le Chesnay'}, 'officialTitle': 'Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)', 'orgStudyIdInfo': {'id': '2015-A01440-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'postoperative nausea and vomiting risk factors', 'description': 'Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.', 'interventionNames': ['Drug: Betamethasone', 'Drug: Droperidol']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors not available for practicians.'}], 'interventions': [{'name': 'Betamethasone', 'type': 'DRUG', 'otherNames': ['Celestene'], 'description': 'Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.', 'armGroupLabels': ['postoperative nausea and vomiting risk factors']}, {'name': 'Droperidol', 'type': 'DRUG', 'otherNames': ['Droleptan'], 'description': 'Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.', 'armGroupLabels': ['postoperative nausea and vomiting risk factors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Parly2', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'On demand'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Privé de Parly II - Le Chesnay', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Sébastien CHAMPION', 'investigatorAffiliation': 'Hôpital Privé de Parly II - Le Chesnay'}}}}