[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561083":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":55,"locations":63,"responsibleParty":86,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":41,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":41,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":65,"whyStopped":41,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Benaroya Research Institute","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Barhemsys","EXPERIMENTAL","Interventional arm receiving Barhemsys during surgery",[13],"Drug: Amisulpride IV Prevention",{"label":15,"type":16,"description":17,"interventionNames":18},"Group Placebo","PLACEBO_COMPARATOR","Placebo arm receiving Placebo during surgery",[19],"Drug: Placebo Preventative",{"label":21,"type":10,"description":22,"interventionNames":23},"Group Placebo Barhemsys","Of patients who are members of Group Placebo they will be able to receive Barhemsys in the Post Anesthesia Care Unit if they experience nausea or emesis",[24],"Drug: Amisulpride IV Treatment",{"label":26,"type":16,"description":27,"interventionNames":28},"Group Placebo Placebo","Of patients who are members of Group Placebo they will be able to receive Placebo in the Post Anesthesia Care Unit if they experience nausea or emesis",[29],"Drug: Placebo Treatment",[31,38,42,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Amisulpride IV Prevention","Patients in this arm will receive Amisulpride 5mg IV as a preventative dose after the induction of anesthesia",[9],[37],"Amisulpride IV Treatment",{"type":32,"name":37,"description":39,"armGroupLabels":40,"otherNames":41},"Patients in this arm will receive Amisulpride 10mg IV for first-line treatment of Post-Operative Nausea and Vomiting in the post-anesthesia care unit.",[21],null,{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Placebo Preventative","Patients in this arm will receive placebo (Normal Saline) while under general anesthesia",[15],{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Placebo Treatment","Patients in this Arm will receive placebo as first line treatment of Post-Operative Nausea and Vomiting in the Post Anesthesia Care Unit",[26],[51],{"name":52,"affiliation":53,"role":54},"Justin S Liberman, Medical Doctor","Virginia Mason Medical Center","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":41,"email":59},"CONTACT","206-341-1298","justin.liberman@vmfh.org",{"name":61,"role":57,"phone":58,"phoneExt":41,"email":62},"David B Auyong, Medical Doctor","David.Auyong@vmfh.org",[64],{"facility":53,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Seattle","Washington","98101","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-122.33207,47.60621,{"lat":75,"lon":74},[78,80,82,84],{"name":79,"role":57,"phone":58,"phoneExt":41,"email":59},"Justin S Liberman, MD MPH",{"name":81,"role":57,"phone":58,"phoneExt":41,"email":62},"David B Auyong, MD",{"name":83,"role":54,"phone":41,"phoneExt":41,"email":41},"Justin S Liberman, MD",{"name":81,"role":85,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"type":54,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Justin Liberman","Staff Anesthesiologist, Department of Anesthesia",[90],{"name":91,"class":6},"Virginia Mason Hospital\u002FMedical Center","100561083","phase-3-a-pilot-study-to-evaluate-barhemsys-for-the-prevention-of-postoperative-nausea-and-vomiting-in-the-bariatric-surgery-population-100561083",false,"NCT06585540","A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea And Vomiting in the Bariatric Surgery Population","Inclusion Criteria:\n\n* The study will recruit adult patients (Age 18-65) scheduled for bariatric surgery. Additional inclusion criteria include ASA class I-III and patients who plan to be inpatient for at least 24 hours.\n\nIncluded Surgeries:\n\nRobotic, Laparoscopic or Open Roux-en-Y Robotic, Laparoscopic or Open Gastric Sleeve Robotic, Laparoscopic or Open Gastrectomy Robotic, Laparoscopic or Open Revision Gastric Bypass\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Congenital QTc abnormalities\n* Current use of droperidol\n* Parkinson's disease\n* Allergy to Barhemsys\n* GFR \\< 30 mL\u002Fmin\u002F1.73m2\n* Emergency surgery or add-on cases",true,"ALL","18 Years","65 Years",{"count":103,"type":104},100,"ESTIMATED","INTERVENTIONAL",[107],"PHASE3","To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.",[110],"Post Operative Nausea and Vomiting",[110,112,113,114,115],"Bariatric Surgery","Bariatric","Barhemsys","Amisulpride","2024-09-24",{"date":118,"type":119},"2024-09-26","ACTUAL",{"date":121,"type":119},"2024-09-13",{"date":123,"type":104},"2026-01",{"name":5,"class":6},1]