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Study identifier: NCT07714785 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Impact of EEG-guided Sevofluorane on Opioid Consumption and Quality of Awakening

Condition: Pediatric Anesthesia · Emergence Delirium, Anesthesia · Postoperative Pain  ·  Sponsor: Pontificia Universidad Catolica de Chile

PhaseNA
Planned participants50
Who can joinAll sexes, 2 Years to 8 Years
Healthy volunteersNo

About this study

This prospective, randomized, single-blind, two-arm parallel-group clinical trial evaluates whether EEG-guided sevoflurane titration affects intraoperative opioid consumption and emergence quality in children undergoing painful elective surgery without regional anesthesia. Children aged 2-8 years (ASA I-II) scheduled for elective tonsillectomy (±adenoidectomy) are randomized 1:1 to a Control Group (standard 1 age-adjusted MAC; EEG screen concealed) or a Study Group (sevoflurane titrated to a stable slow-delta/alpha EEG pattern, SEF 17-20 Hz, starting at \~0.7 MAC). In both arms, fentanyl (0.5-1 mcg/kg IV) is added when nociception signs occur. The primary outcome is intraoperative fentanyl consumption (mean mcg/kg rate). Secondary outcomes include sevoflurane exposure (EtSevo, MAC-hours), EEG burst suppression, emergence time, emergence delirium (PAED scale), postoperative pain and opioid use, and hemodynamic events. Sample size: 50 participants (25/arm; 90% power, α=0.05, expected difference 2 mcg/kg, SD=2). EEG spectral analysis is performed in MATLAB using multitaper frequency-domain bootstrap. The study has institutional ethics approval; parental consent and patient assent (≥7 years) are obtained prior to enrollment.

This description comes directly from the study's public registry record.

Talk to the study team

Mauricio Ibacache, Phd  ·  +56984421425  ·  mianesteman@gmail.com

Ricardo Fuentes, MD  ·  +56984421425  ·  rfuente@ucchristus.cl

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital UC ChristusSantiago, Región, ChileRecruiting

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Source record: clinicaltrials.gov/study/NCT07714785