Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-24 @ 5:40 AM
Study NCT ID:
NCT02194192
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'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'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2014-07-16', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Apgar score', 'timeFrame': 'one minute and five minute after delivery'}], 'primaryOutcomes': [{'measure': 'Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.', 'timeFrame': 'After spinal block to until baby delivered', 'description': 'Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.'}], 'secondaryOutcomes': [{'measure': 'Maternal symptom: Nausea and vomiting after spinal anesthesia', 'timeFrame': 'After spinal anesthesia until baby delivered'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prevention of hypotension', 'spinal anesthesia', 'cesarean section', 'ephedrine', 'ondansetron'], 'conditions': ['Anesthesia; Adverse Effect, Spinal and Epidural']}, 'referencesModule': {'references': [{'pmid': '22100822', 'type': 'BACKGROUND', 'citation': 'Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.'}, {'pmid': '18675744', 'type': 'BACKGROUND', 'citation': 'Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszulowicz R, Dylczyk-Sommer A, Wujtewicz MA, Sawicka W, Morzuch E, Smietanski M, Wujtewicz M. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):332-9. doi: 10.1016/j.rapm.2008.01.010.'}, {'pmid': '12067872', 'type': 'BACKGROUND', 'citation': 'Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. doi: 10.1007/BF03017387.'}, {'pmid': '17054153', 'type': 'BACKGROUND', 'citation': 'Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.'}, {'pmid': '14742392', 'type': 'BACKGROUND', 'citation': 'Lee A, Ngan Kee WD, Gin T. A dose-response meta-analysis of prophylactic intravenous ephedrine for the prevention of hypotension during spinal anesthesia for elective cesarean delivery. Anesth Analg. 2004 Feb;98(2):483-490. doi: 10.1213/01.ANE.0000096183.49619.FC.'}]}, 'descriptionModule': {'briefSummary': 'Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. It can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis.\n\nMany interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish reflex.\n\nThis aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Elective cesarean section\n* Patient accept spinal anesthesia\n* ASA classification I-II\n* Term, Singleton pregnancy\n* Understand all process in this study\n\nExclusion Criteria:\n\n* DM any type that not the gestational DM\n* Hypertensive disorder\n* BMI\\>40\n* Complicated pregnancy such as placenta previa, preeclampsia\n* Allergic to study drugs\n* Long QT syndrome\n* Contraindication to spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT02194192', 'briefTitle': 'Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '810/2556(EC2)'}, 'secondaryIdInfos': [{'id': '(IO)R015731034', 'type': 'OTHER_GRANT', 'domain': 'Faculty of medicine Siriraj Hospital, Mahidol University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group E', 'description': 'Ephedrine 10 mg in Normal Saline 10 ml', 'interventionNames': ['Drug: Ephedrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group O', 'description': 'Ondansetron 8 mg in Normal saline 10 ml', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group P', 'description': 'Normal saline 10 ml', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal saline 10 ml', 'armGroupLabels': ['Group P']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': 'Ondasetron 8 mg IV after spinal anesthesia', 'armGroupLabels': ['Group O']}, {'name': 'Ephedrine', 'type': 'DRUG', 'description': 'Ephedrine 10 mg IV after spinal anesthesia', 'armGroupLabels': ['Group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Patchareya Nivatpumin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}