Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04533867
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2020-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2020-08-09', 'studyFirstSubmitQcDate': '2020-08-29', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional living index- Emesis', 'timeFrame': 'postoperative seventh day', 'description': 'Quality of life after discharge about emesis using Functional living index- Emesis'}], 'primaryOutcomes': [{'measure': 'Nause and vomiting 6hr', 'timeFrame': 'postoperative 6 hours', 'description': 'Visual Analog Scale score for nausea and vomiting'}, {'measure': 'Nause and vomiting 24hr', 'timeFrame': 'postoperative 24 hours', 'description': 'Visual Analog Scale score for nausea and vomiting'}, {'measure': 'Nause and vomiting 48hr', 'timeFrame': 'postoperative 48 hours', 'description': 'Visual Analog Scale score for nausea and vomiting'}, {'measure': 'Nause and vomiting 72hr', 'timeFrame': 'postoperative 72 hours', 'description': 'Visual Analog Scale score for nausea and vomiting'}, {'measure': 'amount of rescue anti-emetic drugs', 'timeFrame': 'postoperative seventh day', 'description': 'Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.'}], 'secondaryOutcomes': [{'measure': 'Pain 6hr', 'timeFrame': 'postoperative 6 hours', 'description': 'Visual Analog Scale score for pain'}, {'measure': 'Pain 24hr', 'timeFrame': 'postoperative 24 hours', 'description': 'Visual Analog Scale score for pain'}, {'measure': 'Pain 48hr', 'timeFrame': 'postoperative 48 hours', 'description': 'Visual Analog Scale score for pain'}, {'measure': 'Pain 72hr', 'timeFrame': 'postoperative 72 hours', 'description': 'Visual Analog Scale score for pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nausea, Postoperative', 'Vomiting, Postoperative', 'Patient Reported Outcomes', 'Pain, Postoperative', 'Antiemetics']}, 'referencesModule': {'references': [{'pmid': '31384338', 'type': 'RESULT', 'citation': 'Aydin A, Kacmaz M, Boyaci A. Comparison of ondansetron, tropisetron, and palonosetron for the prevention of postoperative nausea and vomiting after middle ear surgery. Curr Ther Res Clin Exp. 2019 Jun 22;91:17-21. doi: 10.1016/j.curtheres.2019.06.002. eCollection 2019.'}, {'pmid': '30976908', 'type': 'RESULT', 'citation': 'Lee S, Kim I, Pyeon T, Lee S, Song J, Rhee J, Jeong S. Population pharmacokinetics of palonosetron and model-based assessment of dosing strategies. J Anesth. 2019 Jun;33(3):381-389. doi: 10.1007/s00540-019-02641-5. Epub 2019 Apr 11.'}, {'pmid': '31198253', 'type': 'RESULT', 'citation': 'Rajnikant K, Bhukal I, Kaloria N, Soni SL, Kajal K. Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy. Anesth Essays Res. 2019 Apr-Jun;13(2):317-322. doi: 10.4103/aer.AER_21_19.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.', 'detailedDescription': 'Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'obese patients underwent laparoscopic sleeve gastrectomy', 'genderDescription': 'between 18-65 years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All morbidity obese patients underwent laparoscopic sleeve gastrectomy\n\nExclusion Criteria:\n\ndrug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.'}, 'identificationModule': {'nctId': 'NCT04533867', 'briefTitle': 'Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery', 'orgStudyIdInfo': {'id': 'Beren Hacım 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ondansetron', 'description': 'In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.', 'interventionNames': ['Procedure: Laparoscopic sleeve gastrectomy', 'Drug: Ondansetron 1 mg/kg, max dose 8 mg']}, {'label': 'Palonosetron', 'description': 'The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.', 'interventionNames': ['Procedure: Laparoscopic sleeve gastrectomy', 'Drug: Palonosetron 1mcg/kg']}], 'interventions': [{'name': 'Laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape', 'armGroupLabels': ['Ondansetron', 'Palonosetron']}, {'name': 'Palonosetron 1mcg/kg', 'type': 'DRUG', 'description': 'Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.', 'armGroupLabels': ['Palonosetron']}, {'name': 'Ondansetron 1 mg/kg, max dose 8 mg', 'type': 'DRUG', 'description': 'Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.', 'armGroupLabels': ['Ondansetron']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bagcılar Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Surp Pırgic Armenian Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ali Solmaz, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Private Camlıca Erdem Hospital/Istanbul-TURKEY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pirincipal investigator Adnan', 'investigatorFullName': 'Nadir Adnan Hacım', 'investigatorAffiliation': 'Bagcilar Training and Research Hospital'}}}}