Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT03185156
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2017-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '60 maternal aged 20-40 years will be collected'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-21', 'studyFirstSubmitDate': '2017-06-10', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of nausea and vomiting', 'timeFrame': '24 hours', 'description': 'the patients were not asked directly about nausea during the course of the surgery, but its incidence was recorded when spontaneously reported vomiting was recorded as observed by investigator'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nausea and vomiting', 'hemabate', 'propofol'], 'conditions': ['Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '33993473', 'type': 'DERIVED', 'citation': 'Bi Y, Zhong R, Huang J, Huang H. Effect of continuous infusion of a subhypnotic dose of propofol on nausea and vomiting after carboprost administration at cesarean delivery: A randomized, double-blind, placebo-controlled trial. Int J Gynaecol Obstet. 2022 May;157(2):283-288. doi: 10.1002/ijgo.13742. Epub 2021 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo-controlled trail, the objective of this study is observation the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the presence of post-delivery intra-operative nausea and vomiting in parturients. The patients demographic characteristics, blood pressure, sensory block level, and the medications will be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20-40 years;\n* American Standards Association status I-II.\n\nExclusion Criteria:\n\n* Patients with allergy or hypersensitivity to propofol, lipid emulsion, or granisetron;\n* History of nausea or vomiting within 24h before cesarean delivery;\n* History of gastrointestinal or psychiatric disease, motion sickness, smoking, postoperative nausea and vomiting;\n* Morbid obesity;\n* Consumption of drugs such as opioids, antiemetics , H2 antagonists, phenothiazines and/or corticosteroids within 24h before the study period;\n* Any chronic medical or surgical disorders complicating the pregnancy;\n* Conditions contraindicating regional anesthesia.'}, 'identificationModule': {'nctId': 'NCT03185156', 'briefTitle': 'The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate', 'organization': {'class': 'OTHER', 'fullName': 'West China Second University Hospital'}, 'officialTitle': 'The Preventive Effect of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate', 'orgStudyIdInfo': {'id': 'WESTCHINASUHA-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'propofol group', 'description': 'first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump', 'interventionNames': ['Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump', 'armGroupLabels': ['propofol group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Second University Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES', 'description': 'published in paper form'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Second University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yanmei-Bi', 'investigatorAffiliation': 'West China Second University Hospital'}}}}