Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-07 @ 12:35 AM
Study NCT ID:
NCT02021851
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Nausea and Vomiting in Patients After 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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077608', 'term': 'Aprepitant'}, {'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': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'One year', 'description': 'Opioid consumption'}], 'primaryOutcomes': [{'measure': 'Complete response', 'timeFrame': 'One year', 'description': 'The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.'}], 'secondaryOutcomes': [{'measure': 'Nausea', 'timeFrame': 'One year', 'description': 'The secondary outcome measure is incidence of nausea'}, {'measure': 'Retching', 'timeFrame': 'One year', 'description': 'The secondary outcome measure is incidence of retching'}, {'measure': 'Vomiting', 'timeFrame': 'One year', 'description': 'The secondary outcome measure is incidence of vomiting'}, {'measure': 'Need of rescue antiemetic', 'timeFrame': 'One year', 'description': 'The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexamethasone,', 'Ondansetron', 'Aprepitant', 'PONV', 'Laparoscopic surgery'], 'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': "Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.\n\nSeventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.\n\nPONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P\\<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years to 60 Years\n* ASA (American Society of Anesthesiologist) physical status I or II\n* Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Hypersensitivity or contraindication to the study medications,\n* Antiemetic drug or steroid use within 24 hours before anesthesia,\n* History of diabetes mellitus,\n* History of motion sickness or postoperative nausea and vomiting,\n* Pregnancy,\n* Breast feeding'}, 'identificationModule': {'nctId': 'NCT02021851', 'briefTitle': 'Prevention of Nausea and Vomiting in Patients After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University Hospital'}, 'officialTitle': 'THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY', 'orgStudyIdInfo': {'id': '125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group DA: Dexamethasone and aprepitant', 'description': 'Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)', 'interventionNames': ['Drug: Dexamethasone and aprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group DO: Dexamethasone and ondansetron', 'description': 'Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)', 'interventionNames': ['Drug: Dexamethasone and ondansetron']}], 'interventions': [{'name': 'Dexamethasone and aprepitant', 'type': 'DRUG', 'armGroupLabels': ['Group DA: Dexamethasone and aprepitant']}, {'name': 'Dexamethasone and ondansetron', 'type': 'DRUG', 'armGroupLabels': ['Group DO: Dexamethasone and ondansetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34752', 'city': 'Devlet Yolu, Ankara Cad 102/104', 'state': 'Kozyatagi Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sevgi Bilgen', 'investigatorAffiliation': 'Yeditepe University Hospital'}}}}