Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAssiut University

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine and Propofol

    Drug

    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.

  • Sevoflurane

    Drug

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group KP: Ketamine-Propofol TIVAExperimental treatment 1 intervention
Group B: Group S: Sevoflurane-Based AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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