caudal block: In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.
Study summary
This study aims to evaluate the effects of minimal-flow sevoflurane compared with high-flow sevoflurane during maintenance of general anesthesia on postoperative emergence agitation in opioid-free pediatric infraumbilical surgeries. Patients will be randomly assigned to receive either opioid-free minimal-flow anesthesia combined with caudal block or opioid-free high-flow anesthesia combined with caudal block.
The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale and the Watcha scale. Secondary outcomes include the incidence of postoperative nausea and vomiting and recovery characteristics. In addition, all patients will be followed up via telephone at 3 months postoperatively to assess the presence of persistent chronic or neuropathic pain at the surgical site.
The findings of this study may contribute to optimizing anesthesia strategies and improving postoperative outcomes in pediatric patients.
Eligibility
Sex
ALL
Min age
2 Years
Max age
10 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Pediatric patients aged 2-10 years
* ASA physical status I-II
* Scheduled for elective infraumbilical surgery
* Planned to receive general anesthesia with caudal block
* Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
* \- Refusal of parental consent
* Known allergy to study drugs
* Neurological or developmental disorders
* Psychiatric disorders or use of psychoactive medications
* Chronic pain or regular analgesic use
* Contraindication to caudal block (infection at site, coagulopathy, anatomical abnormality)
* Significant cardiovascular, respiratory, hepatic, or renal disease
* Emergency surgery
* Signs of failed caudal epidural block, defined as a greater than 20% increase in heart rate or blood pressure in response to surgical stimulation, an increase in bispectral index (BIS) values, or the requirement for additional intravenous anesthetic agents.
Primary outcome measure(s)
Emergence agitation assessed by Pediatric Anesthesia Emergence Delirium scale — First 30 minutes in PACU Pediatric Anesthesia Emergence Delirium (PAED) Scale score ranging from 0 to 20 points. Higher scores indicate more severe emergence delirium. Emergence delirium will be defined as a PAED score ≥10.
Trial sites (1)
Facility
City
Region
Status
Ankara Bilkent City Hospital
Ankara
Turkey (Türkiye)
More Ankara City Hospital Bilkent trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.