Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT03933605
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2019-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
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': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-28', 'studyFirstSubmitDate': '2019-04-28', 'studyFirstSubmitQcDate': '2019-04-28', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': '24 hours after surgery', 'description': '0=none; 1=occur'}, {'measure': 'severity of postoperative nausea and vomiting', 'timeFrame': '24 hours after surgery', 'description': '0 = absent; 1 = mild; 2 = moderate; 3 = severe'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative nausea and vomiting', 'midazolam', 'palonosetron'], 'conditions': ['Postoperative Nausea', 'Postoperative Vomiting']}, 'descriptionModule': {'briefSummary': 'In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2\n\nExclusion Criteria:\n\n* The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index \\> 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT03933605', 'briefTitle': 'Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yeungnam University College of Medicine'}, 'officialTitle': 'Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'YUMC 2017-04-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'midazolam and palonosetron', 'description': '0.05 mg/kg of midazolam i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction', 'interventionNames': ['Drug: midazolam and palonosetron group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'palonosetron', 'description': 'the same volume (0.05 mg/kg) of normal saline i.v. with 0.075 mg of palonosetron i.v. was administered after anesthetic induction', 'interventionNames': ['Drug: palonosetron group']}], 'interventions': [{'name': 'midazolam and palonosetron group', 'type': 'DRUG', 'description': 'intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting', 'armGroupLabels': ['midazolam and palonosetron']}, {'name': 'palonosetron group', 'type': 'DRUG', 'description': 'intravenous palonosetron administraion as prevention of postoperative nausea and vomiting', 'armGroupLabels': ['palonosetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41944', 'city': 'Daegu', 'state': 'Korea (the Republic Of)', 'country': 'South Korea', 'facility': 'Eun kyung Choi', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeungnam University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Kyung Choi', 'investigatorAffiliation': 'Yeungnam University College of Medicine'}}}}