Minimal- Versus High-Flow Sevoflurane and Emergence Agitation in Pediatric Surgery
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 80 people, planned
- Started
- 22 Apr 2026
- Ended
- 30 Jun 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- caudal block
- Record updated
- 9 June 2026
Who can take part
- Age
- 2 years to 10 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Emergency surgery
- Known allergy to study drugs
- Neurological or developmental disorders
- Psychiatric disorders or use of psychoactive medications
- Contraindication to caudal block (infection at site, coagulopathy, anatomical abnormality)
- Significant cardiovascular, respiratory, hepatic, or renal disease
- 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
- - Refusal of parental consent
- Chronic pain or regular analgesic use
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- opioid-free minimal-flow anesthesiaTreatment being tested
In this arm, pediatric patients undergoing infraumbilical surgery under opioid-free general anesthesia receive a caudal epidural block after tracheal intubation. Anesthesia is then maintained with minimal-flow sevoflurane.
Treatment: caudal block
- Opioid-Free High-Flow anesthesiaTreatment being tested
Patients receive opioid-free high-flow sevoflurane anesthesia during maintenance of general anesthesia combined with caudal block.
Treatment: caudal block
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of the Effects of Minimal-Flow and High-Flow Sevoflurane on Emergence Agitation in Opioid-Free Pediatric Surgeries During General Anesthesia Maintenance
- Record updated
- 9 June 2026