[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659863":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":23,"interventions":36,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":46,"collaborators":13,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":13,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":13,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":79,"whyStopped":13,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Postoperative Vomiting","Incidence is assessed as the percentage of participants who experience at least one episode of postoperative vomiting or retching. Retching is evaluated as equivalent to vomiting, as nausea is not assessed independently in this pediatric population.","Up to 24 hours postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","OUTCOMES_ASSESSOR",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Group KP: Ketamine-Propofol TIVA","EXPERIMENTAL","Patients receive total intravenous anesthesia (TIVA). Induction consists of intravenous ketamine 1 mg\u002Fkg followed by propofol 2 mg\u002Fkg, with atracurium 0.5 mg\u002Fkg to facilitate endotracheal intubation. Maintenance is provided with a continuous intravenous infusion of ketamine at 2 mg\u002Fkg\u002Fh and a stepped manual intravenous infusion of propofol (15 mg\u002Fkg\u002Fh for 0-15 min, 13 mg\u002Fkg\u002Fh for 15-30 min, and 11 mg\u002Fkg\u002Fh for 30-60 min, titrated thereafter). Mechanical ventilation is delivered with 50% oxygen in air. All patients receive IV dexamethasone 0.2 mg\u002Fkg after induction for antiemetic prophylaxis. Infusions are stopped at the end of surgery.",[29],"Drug: Ketamine and Propofol",{"label":31,"type":32,"description":33,"interventionNames":34},"Group S: Sevoflurane-Based Anesthesia","ACTIVE_COMPARATOR","Patients receive inhalational general anesthesia. Anesthesia is induced with sevoflurane and maintained with sevoflurane in a 50% oxygen and 50% air mixture throughout the procedure, adjusted to maintain an age-appropriate minimum alveolar concentration (MAC) of 1.0-1.2. Intravenous atracurium 0.5 mg\u002Fkg is administered to facilitate endotracheal intubation. All patients receive IV dexamethasone 0.2 mg\u002Fkg after induction for antiemetic prophylaxis. Sevoflurane is discontinued at the end of surgery.",[35],"Drug: Sevoflurane",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DRUG","Ketamine and Propofol","Induction with intravenous ketamine 1 mg\u002Fkg followed by propofol 2 mg\u002Fkg. Maintenance via continuous IV infusion of ketamine at 2 mg\u002Fkg\u002Fh alongside a manual stepped IV infusion of propofol (15 mg\u002Fkg\u002Fh for the first 15 minutes, 13 mg\u002Fkg\u002Fh from 15 to 30 minutes, and 11 mg\u002Fkg\u002Fh from 30 to 60 minutes, then adjusted as clinically indicated). Discontinued at the completion of surgery.",[25],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"Sevoflurane","Inhalational general anesthesia induced and maintained with sevoflurane delivered in a 50% oxygen and 50% air mixture. The delivered concentration is adjusted to maintain an age-appropriate minimum alveolar concentration (MAC) of 1.0 to 1.2 throughout the surgical procedure. Administration is discontinued at the end of surgery.",[31],{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mahmoud Yasser Mahmoud Mohammed","Resident","100659863","phase-4-effect-of-ketamine-propofol-total-intravenous-anesthesia-versus-sevoflurane-based-anesthesia-on-postoperative-vomiting-in-children-undergoing-strabismus-surgery-100659863",false,"NCT07871292","Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery","Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery: A Prospective Randomized Clinical Trial","Inclusion Criteria:\n\n* Pediatric patients aged 3 to 12 years.\n* Patients scheduled for elective strabismus surgery under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Patients of both sexes.\n\nExclusion Criteria:\n\n* Refusal of parents or legal guardians to participate in the study.\n* Known allergy or hypersensitivity to propofol, ketamine, sevoflurane, or any other drug used in the anesthetic protocol.\n* Pre-existing cardiovascular disease, significant arrhythmia, or clinically significant conduction abnormality.\n* Significant respiratory disease or active respiratory tract infection at the time of surgery.\n* Known neurological or neuromuscular disorders that may affect anesthetic management or postoperative assessment.\n* Significant hepatic or renal dysfunction.\n* Preoperative nausea or vomiting.\n* Current or recent use of medications that significantly affect postoperative nausea and vomiting (PONV), hemodynamic responses, or emergence from anesthesia.","ALL","3 Years","12 Years",{"count":61,"type":62},50,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","Pediatric strabismus surgery is frequently followed by postoperative nausea and vomiting, which can cause significant discomfort, dehydration, and delayed recovery in young children. The type of general anesthesia administered is an important modifiable factor in preventing these complications. While sevoflurane is commonly used for pediatric anesthesia due to its smooth induction, it is associated with higher rates of postoperative vomiting and emergence agitation. Total intravenous anesthesia (TIVA) using propofol provides antiemetic benefits, and combining it with ketamine may help maintain stable heart rate and blood pressure while reducing emetic episodes.\n\nThe primary purpose of this study is to determine whether ketamine-propofol total intravenous anesthesia reduces the incidence of postoperative vomiting compared with sevoflurane-based general anesthesia in children undergoing elective strabismus surgery.\n\nParticipants aged 3 to 12 years will be randomly assigned to one of two groups:\n\n* Group KP: Receives total intravenous anesthesia (TIVA) using a combination of ketamine and propofol for both induction and maintenance of anesthesia.\n* Group S: Receives inhalational general anesthesia using sevoflurane for both induction and maintenance.\n\nParticipants will be monitored closely during the operation and followed for 24 hours postoperatively. The main outcome measured is the occurrence of postoperative vomiting or retching during the first 24 hours. Additional assessments include postoperative pain scores, heart rate and blood pressure stability, the occurrence of the oculocardiac reflex, emergence agitation, and the requirement for rescue antiemetic or pain medications.",[68,69,70],"Postoperative Vomiting","Postoperative Nausea and Vomiting","Strabismus",[72,73,43,74,75,76,77,78],"Ketamine","Propofol","Total Intravenous Anesthesia","TIVA","Strabismus Surgery","Pediatric Anesthesia","Oculocardiac Reflex","NOT_YET_RECRUITING","2026-10-07",{"date":82,"type":83},"2026-10-13","ACTUAL",{"date":85,"type":62},"2026-11",{"date":87,"type":62},"2027-12",{"name":5,"class":6}]