Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT04411069
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004329', 'term': 'Droperidol'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "The patient didn't know if he received the third anti emetic"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative nausea and vomiting', 'timeFrame': 'from 0 to 24 postoperative hours', 'description': 'record of any episode of nausea and or vomiting in the 24 postoperative hours'}], 'secondaryOutcomes': [{'measure': 'Changing in the institutional protocol', 'timeFrame': 'from the begining to the study to the end of the study (2 years)', 'description': 'number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nausea', 'vomiting', 'chemoterapy'], 'conditions': ['Postoperative Nausea', 'Postoperative Vomiting']}, 'descriptionModule': {'briefSummary': 'Previous history of nausea and vomiting induced by prior chemotherapy still not included as predictive factor of postoperative nausea and vomiting, although has been demonstrated that has influence in postoperative outcome.\n\nThe project aims to evaluate the efficacy of a simplified algorithm in prevention postoperative nausea and vomiting , with pacients with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium or large surgery.', 'detailedDescription': 'Quasi-experimental study, with evaluation after the application of a specific postoperative nausea and vomiting prevention algorithm for cancer patients.\n\nThe study will be carried out in 2 phases:\n\nPhase 1: Team training. In this phase, a protocol was established for PONV prophylaxis, using two questions:\n\n1. Patient undergoing chemotherapy before surgery;\n2. Patient presented chemotherapy induced nausea and vomiting (CINV).\n\nIf the answer is yes to both questions, the anesthetist administers 3 antiemetics (4mg dexametasone, 4mg ondansetron and 0,625mg droperidol). If the answer is no to one of the questions, the anesthetist administers 2 antiemetics (4mg dexametasone and 4mg ondansetron); In this phase, educational measures will be implemented by team meetings and individual approach of all anesthesiologists at ICESP to present the study project and the algorithm. A summary of the the study will be sent daily through the social network Whats App®.\n\nThe number of patients was calculated taking into account adherence to the new prophylaxis protocol for post-operative nausea and vomiting. If we consider an alpha error of 5% and test power of 80%, to have a NVPO reduction of 41% (current overall incidence) to 25% (incidence after protocol adherence) in high-risk patients, we need to study 270 patients (135 each group adherence and non-adherence to the protocol).\n\nPhase 2: Post-training assessment. In the second phase of the study, after the end of the dissemination of the protocol among doctors, the patients will be evaluated on the first postoperative day. The following variables were analyzed: sex, race, age, body mass index, general state of American Society of Anesthesiologist, Apfel scale, type of surgery and anesthesia, use and type of opioids, history of chemotherapy induced nausea and vomiting, type of antiemetics used in the operating room and in the first postoperative day, duration of anesthesia and surgery and nausea and vomiting in 6 and 24 hours after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who underwent medium to large surgery\n\nExclusion Criteria:\n\n* Patients who are unable to communicate (orotracheal intubation after the surgery, confusion or agitation) or understand the Portuguese language;\n* Insulin dependent patients\n* Patients who underwent emergency surgery and neurosurgery\n* Pacients who had an increased QT interval on the electrocardiogram\n* History of allergy to dexametasone, ondansetron or droperidol\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT04411069', 'briefTitle': 'Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital', 'orgStudyIdInfo': {'id': 'NP 1336/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Patients without previous CINV', 'description': "Patients who didn't have chemotherapy or that didn´t have any nausea and/or vomiting induced by chemotherapy (CINV) before surgery"}, {'type': 'OTHER', 'label': 'Patients with previous CINV', 'description': 'Patients who had previous nausea and vomiting induced by chemoterapy.', 'interventionNames': ['Drug: Droperidol']}], 'interventions': [{'name': 'Droperidol', 'type': 'DRUG', 'otherNames': ['Intravenous droperidol'], 'description': 'Pacients who had nausea and vomiting induced by chemotherapy will receive three anti emetic drugs: 4mg dexametasone, 4 mg ondansetron and 0,625 mg droperidol', 'armGroupLabels': ['Patients with previous CINV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Cancer Institute of the State of Sao Paulo - ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Roger Chammas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto do Cancer do Estado de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}