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NOT YET RECRUITING
NCT07871292
PHASE4

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

Sponsor: Assiut University

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

3 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11

Completion Date

2027-12

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Ketamine and 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.

DRUG

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.