RecruitingNot ApplicableNCT07714785

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

Impact of EEG-guided Sevoflurane Titration on Opioid Consumption and Emergency Quality in Pediatric Patients Undergoing Surgery Without Regional Anesthesia


Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

50 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called EEG-guided and a procedure called Standard for people with emergence delirium, anesthesia, pediatric anesthesia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 8 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEEG-guided

Induction with sevoflurane 3% in O₂. Maintenance titrated to the minimum concentration sustaining a continuous slow-delta/alpha EEG pattern (SEF 17-20 Hz), starting at 0.7 age-adjusted MAC in O₂/air FiO₂ 60%.

PROCEDUREStandard

Arm Description: Induction with sevoflurane 5% in O₂. Maintenance at fixed 1 age-adjusted MAC in O₂/air FiO₂ 60%. BIS monitor attached but screen concealed; anesthesiologist blinded to EEG data.


Locations(1)

Hospital UC Christus

Santiago, Región, Chile

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NCT07714785


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