Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT00791960
Status:
COMPLETED
Last Update Posted:
2010-03-29
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
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': 'D004111', 'term': 'Dimenhydrinate'}], 'ancestors': [{'id': 'D004155', 'term': 'Diphenhydramine'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013806', 'term': 'Theophylline'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-25', 'studyFirstSubmitDate': '2008-11-13', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pre or post-delivery nausea as reported by the patient. Nausea will be defined as a subjectively unpleasant sensation associated with urge to vomit.', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Severity of nausea, assessed by visual analog scale (1-10)', 'timeFrame': '2 hours'}, {'measure': 'Presence or absence of retching or vomiting.', 'timeFrame': '2 hours'}, {'measure': 'Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.', 'timeFrame': '2 hours'}, {'measure': 'Type and amount of any rescue antiemetic medication used.', 'timeFrame': '2 hours'}, {'measure': 'Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.', 'timeFrame': '2 hours'}, {'measure': 'Technique of uterine closure (exteriorization vs. in-situ repair).', 'timeFrame': '30 minutes'}, {'measure': 'Dose of opioid used as supplemental intravenous analgesia.', 'timeFrame': '2 hours'}, {'measure': 'Number of episodes of hypotension.', 'timeFrame': '2 hours'}, {'measure': 'Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.', 'timeFrame': '3 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cesarean Section', 'Dimenhydrinate', 'Gravol', 'Antiemetics'], 'conditions': ['Nausea', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '34002866', 'type': 'DERIVED', 'citation': 'Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate (also known as Gravol), given before the induction of spinal anesthesia, will decrease the incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery.\n\nThis medication is commonly given during and after the surgery if required, but it is not known whether a preventative dose will decrease the overall incidence of these side effects.', 'detailedDescription': 'Nausea and vomiting remain one of the most common complications of Cesarean delivery. The results of this study will show whether or not we can improve our present anesthesia regimen, and improve the satisfaction of patients undergoing Cesarean deliveries, by reducing the incidence of nausea and vomiting. Our current practice is not to use any medication for preventing nausea and vomiting unless required. However, nausea and vomiting come quite fast and unexpectedly during the operation, and most of the time the medication we give does not work fast enough. We are planning to study the anti-nausea medication dimenhydrinate (commonly known as Gravol), which has been safely and widely used during pregnancy, labour and Cesarean deliveries, hoping that its use will decrease the incidence of this unpleasant occurrence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing elective Cesarean deliveries under spinal anesthesia.\n* All patients who gave written informed consent to participate in this study.\n* ASA I and II patients.\n* Full term normal pregnancy.\n\nExclusion Criteria:\n\n* All patients who refuse to give written informed consent.\n* All patients who claim allergy or hypersensitivity to dimenhydrinate.\n* Patients with history of vomiting within 24 hours prior to Cesarean delivery.\n* Patients with history of gastrointestinal or psychiatric diseases and morbid obesity\n* Patients receiving any of the following drugs within 24 hours before the study: opioids, antiemetics, H2 antagonists, phenothiazine and corticosteroids.\n* Patients with severe pregnancy induced hypertension'}, 'identificationModule': {'nctId': 'NCT00791960', 'briefTitle': 'Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '08-01'}, 'secondaryIdInfos': [{'id': '08-0206-A'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dimenhydrinate', 'description': 'Dimenhydrinate', 'interventionNames': ['Drug: Dimenhydrinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dimenhydrinate', 'type': 'DRUG', 'otherNames': ['Gravol'], 'description': 'single dose, 25mg, IV, diluted in 9.5mL normal saline.', 'armGroupLabels': ['Dimenhydrinate']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'single dose, 10 mL normal saline, IV', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jose CA Carvalho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Jose C.A. Carvalho', 'oldOrganization': 'Mount Sinai Hospital'}}}}