Association of pharmacological prophylaxis with the risk of pediatric emergence delirium after sevoflurane anesthesia: An updated network meta-analysis.
Hung-Yu Wang, Tien-Yu Chen, Dian-Jeng Li...
https://pubmed.ncbi.nlm.nih.gov/34481361/Actively Recruiting
Led by Pontificia Universidad Catolica de Chile · Updated on 2026-07-22
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating how adjusting sevoflurane anesthesia based on electroencephalography EEG affects opioid use and recovery quality in children aged 2 to 8 years undergoing painful elective tonsillectomy or adenoidectomy without regional anesthesia. This randomized, single-blind trial compares standard sevoflurane dosing with EEG-guided titration to understand its impact on opioid consumption and emergence outcomes. Participants are assigned to one of two groups one receives fixed sevoflurane dosing at 1 age-adjusted MAC with the EEG screen concealed, while the other groups sevoflurane dose is adjusted to maintain a specific EEG pattern starting at about 0.7 MAC. Both groups receive fentanyl as needed based on pain signs. The study measures intraoperative opioid use, sevoflurane exposure, EEG changes, emergence time, delirium, postoperative pain, and hemodynamic events. During the trial, children undergo anesthesia with either standard or EEG-guided sevoflurane dosing and receive opioid administration if necessary. Researchers monitor EEG patterns, opioid consumption, emergence quality, and postoperative pain using scales like the PAED scale. Parental consent and child assent are obtained, and assessments include EEG spectral analysis. The study aims to provide insights into anesthesia management and recovery quality in pediatric surgery, with participation lasting through the surgery and immediate postoperative period.
CONDITIONS
Impact of EEG-guided Sevofluorane on Opioid Consumption and Quality of Awakening
M
Mauricio Ibacache, Phd
R
Ricardo Fuentes, MD
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Pontificia Universidad Catolica de Chile
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery
Participants receive anesthesia with either standard fixed-dose sevoflurane or EEG-guided sevoflurane titration during surgery. Opioids are given as needed based on pain signs.
1 surgical visit
Duration - Immediate postoperative period
Participants are monitored for emergence quality, pain levels, opioid use, and hemodynamic stability during the recovery period after surgery.
1 follow-up visit
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/40257811/Pontificia Universidad Catolica de Chile
Lead Sponsor