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Completed
NCT07714785
Impact of EEG-guided Sevofluorane on Opioid Consumption and Quality of Awakening
Conditions: Pediatric Anesthesia, Emergence Delirium, Anesthesia, Postoperative Pain, Tonsillectomy
Sex: All
Ages: 2 Years – 8 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Pontificia Universidad Catolica de Chile
Location: Hospital UC Christus Santiago Región
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 Criteria
Inclusion Criteria:
* Age 2-8 years
* ASA Physical Status I or II
* Elective tonsillectomy (±adenoidectomy)
* Signed parental consent (and assent ≥7 years)
Exclusion Criteria:
* Neurological or psychiatric disorders
* Growth or developmental delay
* Known allergy to study medications
* Coagulation disorders
* Parental or patient refusal
Source: ClinicalTrials.gov (NCT07714785). StuddyBuddy aggregates publicly available trial information.