Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-31 @ 5:29 AM
Study NCT ID:
NCT02386059
Status:
UNKNOWN
Last Update Posted:
2015-03-11
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia
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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery', 'timeFrame': '1-24 hours post-operatively'}], 'secondaryOutcomes': [{'measure': '• Standardized score of nausea and/or vomiting severity if PONV occurs.', 'timeFrame': '1-24 hours post-operatively'}, {'measure': '• Pain score during the immediate post-operative period.', 'timeFrame': '1-24 hours post-operatively'}, {'measure': '• Number of antiemetic rescue medications given postoperatively.', 'timeFrame': '1-24 hours post-operatively'}, {'measure': '• Rates of known side effects.', 'timeFrame': '1-24 hours post-operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ondansetron', 'dexamethasone', 'vitrectomy', 'local anesthesia'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.\n\nTo date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.\n\nIn this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.', 'detailedDescription': 'Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.\n\nThe syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.\n\nAll vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.\n\nEach patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II\n* Scheduled for vitrectomy under local anesthesia\n\nExclusion Criteria:\n\n* Hypersensitivity to study drug or rescue medication\n* Preoperative score for nausea greater than 4 out of 10 points\n* Subjects who suffer from chronic nausea and/or vomiting\n* Severe hepatic insufficiency (Child-Pugh score \\> 9)\n* Other antiemetic within 12 hours prior to surgery\n* Patients unable to undergo a local anesthetic\n* Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease\n* Psychotic illness or depression\n* Addiction to illicit substances or alcohol\n* Non-psychotic emotional disorders\n* Pregnant or lactating\n* Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug'}, 'identificationModule': {'nctId': 'NCT02386059', 'briefTitle': 'Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia', 'orgStudyIdInfo': {'id': 'UCatania'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO Group', 'description': 'Received normal saline', 'interventionNames': ['Drug: PLACEBO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEXAMETHASONE Group', 'description': 'Received 4 mg Dexamethasone.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ONDANSETRON', 'description': 'Received 4 mg Ondansetron', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEXAMETHASONE + ONDANSETRON', 'description': 'Received 4mg Dexamethasone + 4mg Ondansetron', 'interventionNames': ['Drug: Dexamethasone + Ondansetron']}], 'interventions': [{'name': 'PLACEBO', 'type': 'DRUG', 'description': 'received normal saline, intravenously', 'armGroupLabels': ['PLACEBO Group']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '4 mg, intravenously, at the start of surgery', 'armGroupLabels': ['DEXAMETHASONE Group']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': '4 mg, intravenously, 15 minutes before the end of surgery.', 'armGroupLabels': ['ONDANSETRON']}, {'name': 'Dexamethasone + Ondansetron', 'type': 'DRUG', 'description': '4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery.', 'armGroupLabels': ['DEXAMETHASONE + ONDANSETRON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'MARIO ROMANO, professor', 'role': 'CONTACT', 'phone': '+39 081 5666780'}], 'facility': 'Federico II University', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Sassari', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'University of Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '95125', 'city': 'Catania', 'state': 'Sicily', 'country': 'Italy', 'facility': 'University of Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Ancona', 'state': 'The Marches', 'country': 'Italy', 'facility': 'Polytechnic University of Marche', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}], 'centralContacts': [{'name': 'MICHELE REIBALDI, Professor', 'role': 'CONTACT', 'email': 'mreibaldi@libero.it', 'phone': '+39 0953781291'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'REIBALDI MICHELE', 'investigatorAffiliation': 'University of Catania'}}}}