[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578406":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":56,"collaborators":25,"id":59,"slug":25,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Perineural ondansetron group","EXPERIMENTAL","Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.",[13],"Drug: Perineural ondansetron",{"label":15,"type":16,"description":17,"interventionNames":18},"Intravenous ondansetron group","ACTIVE_COMPARATOR","Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml saline. At the same time, 4 mg (2 ml) ondansetron mixed with 13 ml saline (total 15 ml) will be slowly injected IV over 15 minutes.",[19],"Drug: Intravenous ondansetron",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Perineural ondansetron",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Intravenous ondansetron",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Osama M Rehab, MD","CONTACT","01095210806","osamarehab@med.tanta.edu.eg",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Tanta University Hospitals","RECRUITING","Tanta","Gharbia Governorate","31527","Egypt",{"type":44,"coordinates":45},"Point",[46,47],31.00192,30.78847,{"lat":47,"lon":46},[50,51,53],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":31,"role":52,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"Doha M Bakr, MD","SUB_INVESTIGATOR",{"type":52,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Osama Rehab","lecturer of anesthesiology, surgical intensive care and pain medicine","100578406",false,"NCT06810882","Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy","Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial","Inclusion Criteria:\n\n* Patients of either sex\n* American Society Anesthesiologists physical (ASA) status II-III\n* age between 18-65 years old\n* Body mass index (BMI) \\>35 kg\u002Fm2 with comorbidity or \\> 40 kg\u002Fm2 -- undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade..\n\nExclusion Criteria:\n\n* Allergy to experimental drugs.\n* Known to have long QT, previous history of postoperative nausea and vomiting\n* Abuse of alcohol, analgesia, or sedative antidepressant drugs\n* Chronic pain disorders\n* History of previous upper gastrointestinal system surgery, those with surgery-related complications during or after surgery.\n* Liver or kidney failure\n* Performance of concomitant procedures in addition to laparoscopic sleeve gastrectomy\n* Anesthetic complications that may alter the postoperative management protocol.","ALL","18 Years","65 Years",{"count":69,"type":70},482,"ESTIMATED","INTERVENTIONAL",[73],"NA","This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.",[76,77,78],"Ondansetron","Laparoscopic","Gastrectomy",[76,77,78],"2026-05-13",{"date":82,"type":83},"2026-05-15","ACTUAL",{"date":85,"type":83},"2025-02-16",{"date":87,"type":70},"2027-02-17",{"name":5,"class":6},1]