Clinical Trial

Low Flow Anesthesia in Children Undergoing Strabismus Surgery

Study acronym: LFA in child
Not Yet Recruiting Phase 4
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Record status
This record was last updated August 26, 2024 (before its estimated June 4, 2025 completion). Its status may not reflect the trial's current state.
Summary
Emergence agitation (EA) involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. Sevoflurane and desflurane have increased the incidence of EA in children. A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function, due to differences in clearance of inhalational anesthetics from the central nervous system; whereas audition and locomotion recover first, cognitive function recovers later, resulting in EA. Low-flow anaesthesia (LFA) occurs when the fresh gas flow (FGF) is significantly lower than the patient's minute volume. In a low-flow system, the recirculated fraction should amount to at least 50% after carbon dioxide (CO2) absorption.In LFA using minimal FGF (250-500 mL/min), if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed, the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more. In a study conducted on infants undergoing cleft lip-palate surgery, it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 0.5 L/min FGF. Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA (40-86%). The incidence of EA after strabismus surgery is high, especially due to visual disturbances; however, the pathogenesis of this condition remains unclear. In our study, the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-15.
Trial Details
NCT Number NCT06560268
Lead Sponsor Cukurova University
Conditions Low Flow Anesthesia, Sevoflurane, Strabismus, Emergence Delirium
Enrollment 150 participants
Start Date 2024-11-04
Primary Completion 2025-06-04 (estimated)
Study Completion 2025-07-04 (estimated)
Updated on ClinicalTrials.gov 2024-08-26