Not Yet RecruitingPhase 4ketamine

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

Sponsored by Assiut University

NCT ID
NCT07871292
Target Enrollment
50 participants
Start Date
2026-11
Est. Completion
2027-12

About This Study

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.

Conditions Studied

Postoperative VomitingPostoperative Nausea and VomitingStrabismus

Interventions

  • •Ketamine and Propofol
  • •Sevoflurane

Eligibility

Age:3 Years - 12 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source