Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-29 @ 5:40 AM
Study NCT ID:
NCT05773950
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-30
First Post:
2023-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention
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': 'C579707', 'term': 'fosaprepitant'}, {'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of Postoperative nausea and vomiting', 'timeFrame': 'during 24 hours after surgery', 'description': 'yes or no'}], 'secondaryOutcomes': [{'measure': 'the incidence of Postoperative nausea and vomiting', 'timeFrame': 'during post-anesthesia care unit stay, during 6 hours after surgery', 'description': 'yes or no'}, {'measure': 'the severity of Postoperative nausea and vomiting', 'timeFrame': 'during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery', 'description': 'numeric rating scale 0-10 and PONV impact scale'}, {'measure': 'rescue antiemetics', 'timeFrame': 'during 24 hours after surgery', 'description': 'dose'}, {'measure': 'time to rescue antiemetics', 'timeFrame': 'during 24 hours after surgery', 'description': 'the first administration time point of rescue antiemetics'}, {'measure': 'postoperative pain at rest and couging', 'timeFrame': 'during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery', 'description': 'numeric rating scale 0-10'}, {'measure': 'opioid consumption', 'timeFrame': 'during 24 hours after surgery', 'description': 'morphine equivalent dose'}, {'measure': 'Any adverse event', 'timeFrame': 'during 24 hours after surgery', 'description': 'yes or no'}, {'measure': 'Time to normal diet', 'timeFrame': 'during 24 hours after surgery', 'description': 'time of succes of normal diet'}, {'measure': 'Qualityof recovery from surgery and anesthesia', 'timeFrame': 'during 24 hours after surgery', 'description': 'QoR 15K questionairre'}, {'measure': 'Time to first flatus', 'timeFrame': 'during in hospital stay, an average of 5 days', 'description': 'gas out time pointsyes or no'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PONV', 'fosaprepitant', 'dexamethasone', 'palonosetron'], 'conditions': ['Postoperative Nausea and Vomiting', 'Gynecologic Surgical Procedures', 'Laparoscopy']}, 'descriptionModule': {'briefSummary': 'As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.', 'detailedDescription': 'Intervention\n\n1. Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg,\n2. Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic gynecological surgery.\n* Adults between the ages of 18 and 50\n* American Society of Anesthesiologists Physical Status (ASA physical status I, II\n\nExclusion Criteria:\n\n* American Association of Anesthesiologists physical standards (ASA physical status III or higher)\n* Children under the age of 19\n* Adults over 49 years of age\n* Diabetes Mellitus\n* Pregnant or lactating women\n* Patients with a history of allergy or contraindications for use of the study drug\n* Patients who did not understand this study or expressed their refusal.\n* Patients with a history of serious psychologic disease that may affect the patient evaluation\n* Patients taking serotonergic drugs'}, 'identificationModule': {'nctId': 'NCT05773950', 'briefTitle': 'Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SMC2022-12-050-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dual therapy group', 'description': 'On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants.\n\nIn the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.\n\nThe subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.', 'interventionNames': ['Drug: normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Triple therapy group', 'description': 'On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes.\n\nThe subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.', 'interventionNames': ['Drug: fosaprepitant']}], 'interventions': [{'name': 'fosaprepitant', 'type': 'DRUG', 'otherNames': ['emend'], 'description': 'The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.\n\nIn the experimental group, the subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.', 'armGroupLabels': ['Triple therapy group']}, {'name': 'normal saline', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants.\n\nIn the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.', 'armGroupLabels': ['Dual therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Heejoon Jeong', 'investigatorAffiliation': 'Samsung Medical Center'}}}}