[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573568":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":25},{"fullName":5,"class":6},"Assiut University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"group A","EXPERIMENTAL","fifty patients will receive Caudal epidural block (0.5 mL\u002Fkg of bupivacaine 0.25% plus dexa- methasone 0.1 mg\u002Fkg plus 4mg ondansetron ), and IV 5 mL normal saline",[13,14],"Drug: Dexamethasone and Ondansetron","Drug: Bupivacaine + saline",{"label":16,"type":17,"description":11,"interventionNames":18},"group B","PLACEBO_COMPARATOR",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dexamethasone and Ondansetron","patients will receive Caudal epidural block (0.5 mL\u002Fkg of bupivacaine 0.25% plus dexa- methasone 0.1 mg\u002Fkg plus 4mg ondansetron ), and IV 5 mL normal saline",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Bupivacaine + saline","patients will receive caudal epidural block (0.5 mL\u002Fkg of bupivacaine 0.25% only) and IV 5 mL normal saline",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Abdelrahman Fathy Ahmed Mahny, resident doctor","CONTACT","+20 10 05086251","dr.3bdo202020@gmail.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Abdelrahman Fathy Ahmed","resident doctor at Assiut University hospital","100573568","phase-4-preventative-effect-of-combining-dexamethasone-with-ondansetron-on-postoperative-nausea-vomiting-and-shivering-in-children-undergoing-caudal-anesthesia-on-hypospadias-surgery-100573568",false,"NCT06747975","Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia on Hypospadias Surgery","Preventative Effect of Combining Dexamethasone with Ondansetron on Postoperative Nausea, Vomiting and Shivering in Children Undergoing Caudal Anesthesia","Inclusion Criteria: -\n\n* Age from 2 to 12 years old.\n* Patients with stable vital signs.\n* Patients with normal laboratory investigations.\n* Patients undergoing Caudal anaesthesia for infraumbilical surgeries\n\nExclusion Criteria: -\n\n* Patient's parental refusal.\n* Age \\\u003C 2 or \\> 12 years.\n* Contraindications to Caudal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection ,pilonidal cyst and congenital anomalies of lower spine because of unclear or impalpable anatomy\n* Patients with cardiac morbidities.\n* Failure of caudal block\n* Diabetes mellitus\n* Convulsions.\n* Known allergy to any drugs used in this study.","ALL","2 Years","12 Years",{"count":51,"type":52},100,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","caudal epidural block is a technique used as an adjuvant to general anesthesia for postoperative analgesia in pediatric patients,especially those with infraumbilical, perineal and lower extremity surgery , because it reduces the need for perioperative and postoperative analgesia, reduces the need for general anesthesia, accelerates the awakening, suppresses the surgical neurohumoral stress response and can be performed easily The objective of the current study is to determine the efficacy and safety of prophylactic intravenous administration of combination of 0.1mg\u002Fkg of dexamethasone plus 4mg of ondansetron immediately before establishment of caudal block for prevention of Nausea\\&vomiting and Shivering in pediatric patients undergoing infra umbilical surgeries",[58],"Caudal Anesthesia",[60,61],"dexamethasone","ondansetron","NOT_YET_RECRUITING","2024-12-19",{"date":65,"type":66},"2024-12-24","ACTUAL",{"date":68,"type":52},"2025-01-01",{"date":70,"type":52},"2026-03-01",{"name":5,"class":6}]