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Minimal- Versus High-Flow Sevoflurane and Emergence Agitation in Pediatric Surgery

NCT07635004 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-09

No results posted yet for this 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.

Conditions

  • Postoperative Agitation
  • Emergence Agitation

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2026-06-22
Completion
2026-06-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635004 on ClinicalTrials.gov