[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457197":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":65,"collaborators":53,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":53,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":51,"whyStopped":53,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital, Caen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"control group","ACTIVE_COMPARATOR","intrathecal administration of a solution containing\n\n* bupivacaine 10 mg\n* morphine 100 micrograms\n* sufentanil 3 micrograms",[13],"Other: standardized dose",{"label":15,"type":16,"description":17,"interventionNames":18},"individualized group","EXPERIMENTAL","intrathecal administration of a solution containing\n\n* bupivacaine 0.05 mg per cm of patient's height\n* morphine 100 micrograms\n* sufentanil 3 micrograms",[19],"Other: adjusted dose",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"standardized dose","intrathecal anesthesia with 10 mg of bupivacaine",[9],[26],"standardized dose of bupivacaine",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"adjusted dose","intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height",[15],[32],"adjusted dose of bupivacaine",[34],{"name":35,"affiliation":36,"role":37},"jean-luc hanouz","University Hospital of Caen","STUDY_CHAIR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"jean-luc hanouz, M.D, Ph.D","CONTACT","02 31 06 47 36","+33 1","hanouz-jl@chu-caen.fr",{"name":46,"role":41,"phone":42,"phoneExt":43,"email":47},"thérèse simonet, M.D.","simonet-t@chu-caen.fr",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Caen University Hospital","RECRUITING","Caen",null,"France","FR",{"type":57,"coordinates":58},"Point",[59,60],-0.35912,49.18585,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":53,"phoneExt":53,"email":44},"Jean Luc Hanouz",{"type":66,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100457197","height-adjusted-versus-standardized-dose-of-bupivacaine-for-spinal-anesthesia-100457197",false,"NCT05233462","Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia","Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study","RAMCES","Inclusion Criteria:\n\n* scheduled cesarean section with intrathecal anesthesia\n* term pregnancy \\> 35 weeks\n* signed informed consent\n\nExclusion Criteria:\n\n* unscheduled or emergent cesarean section\n* any contra indication to intrathecal anesthesia\n* any antihypertensive drug prescribed to control arterial pressure during pregnancy\n* pre-eclampsia and eclampsia\n* history of Marfan or Ehlers Danlos disease","FEMALE","18 Years","45 Years",{"count":79,"type":80},250,"ESTIMATED","INTERVENTIONAL",[83],"NA","General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section.\n\nNevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally.\n\nTo date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a \"standardized dose\" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.",[86,87,88],"Regional Anesthesia Morbidity","Cesarean Section Complications","Local Anesthetic Complication",[90,91,92,93],"cesarean section","intrathecal anesthesia","bupivacaine","morbidity","2025-07-22",{"date":96,"type":97},"2025-07-25","ACTUAL",{"date":99,"type":97},"2022-02-23",{"date":101,"type":80},"2026-12-31",{"name":5,"class":6},1]