A Phase 4 interventional study of Ketamine and Propofol and Sevoflurane in Postoperative Vomiting, Postoperative Nausea and Vomiting and Strabismus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Assiut University · Phase 4, Interventional, and Prevention
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.
The 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.
Participants aged 3 to 12 years will be randomly assigned to one of two groups:
Participants 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.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's planned enrollment of 50 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients receive total intravenous anesthesia (TIVA). Induction consists of intravenous ketamine 1 mg/kg followed by propofol 2 mg/kg, with atracurium 0.5 mg/kg to facilitate endotracheal intubation. Maintenance is provided with a continuous intravenous infusion of ketamine at 2 mg/kg/h and a stepped manual intravenous infusion of propofol (15 mg/kg/h for 0-15 min, 13 mg/kg/h for 15-30 min, and 11 mg/kg/h for 30-60 min, titrated thereafter). Mechanical ventilation is delivered with 50% oxygen in air. All patients receive IV dexamethasone 0.2 mg/kg after induction for antiemetic prophylaxis. Infusions are stopped at the end of surgery.
Drug: Ketamine and Propofol
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/kg is administered to facilitate endotracheal intubation. All patients receive IV dexamethasone 0.2 mg/kg after induction for antiemetic prophylaxis. Sevoflurane is discontinued at the end of surgery.
Drug: Sevoflurane
Drug pages: Ketamine · Propofol
Induction with intravenous ketamine 1 mg/kg followed by propofol 2 mg/kg. Maintenance via continuous IV infusion of ketamine at 2 mg/kg/h alongside a manual stepped IV infusion of propofol (15 mg/kg/h for the first 15 minutes, 13 mg/kg/h from 15 to 30 minutes, and 11 mg/kg/h from 30 to 60 minutes, then adjusted as clinically indicated). Discontinued at the completion of surgery.
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.
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.
Time frame: Up to 24 hours postoperatively
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 68 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 68 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketamine · Propofol
Postoperative Nausea and Vomiting →