Postoperative VomitingPhase 4NCT07871292
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
A Phase 4 study testing Ketamine and Propofol and Sevoflurane in people with Postoperative Vomiting and Postoperative Nausea and Vomiting, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Postoperative Vomiting, Postoperative Nausea and Vomiting, Strabismus
- What is being tested?
- Ketamine and Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 3 to 12 years.
- Patients scheduled for elective strabismus surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Patients of both sexes.
Who cannot join
- Refusal of parents or legal guardians to participate in the study.
- Known allergy or hypersensitivity to propofol, ketamine, sevoflurane, or any other drug used in the anesthetic protocol.
- Pre-existing cardiovascular disease, significant arrhythmia, or clinically significant conduction abnormality.
- Significant respiratory disease or active respiratory tract infection at the time of surgery.
- Known neurological or neuromuscular disorders that may affect anesthetic management or postoperative assessment.
- Significant hepatic or renal dysfunction.
- Preoperative nausea or vomiting.
- Current or recent use of medications that significantly affect postoperative nausea and vomiting (PONV), hemodynamic responses, or emergence from anesthesia.
About this study
Official title: Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery: A Prospective Randomized Clinical Trial
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.
Read more
Participants aged 3 to 12 years will be randomly assigned to one of two groups:
- Group KP: Receives total intravenous anesthesia (TIVA) using a combination of ketamine and propofol for both induction and maintenance of anesthesia.
- Group S: Receives inhalational general anesthesia using sevoflurane for both induction and maintenance.
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.
- Being tested
- Ketamine and Propofol, Sevoflurane
- Keywords
- Ketamine, Propofol, Sevoflurane, Total Intravenous Anesthesia, TIVA, Strabismus Surgery, Pediatric Anesthesia, Oculocardiac Reflex
- Medical subject headings
- Postoperative Nausea and Vomiting, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine and PropofolDrug
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.
SevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group KP: Ketamine-Propofol TIVA | Experimental | 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. Receives: Drug: Ketamine and Propofol |
| 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/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. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative VomitingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Yasser Mahmoud Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871292
- Sponsor's protocol ID
- Ketamine-Propofol TIVA vs Sevo
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No