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NCT07714785

Overview

NCT ID: NCT07714785
Lead Sponsor: Pontificia Universidad Catolica de ChileOTHER
Official Title: Impact of EEG-guided Sevoflurane Titration on Opioid Consumption and Emergency Quality in Pediatric Patients Undergoing Surgery Without Regional Anesthesia
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jun 23, 2026Actual
Primary Completion Date: Dec 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 50Estimated
Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Mauricio Ibacache, PhdContact
mianesteman@gmail.com+56984421425

Similar Studies

Masking Description

The Participant (Patient). From the patient's point of view, this metric directly impacts their comfort, safety, and recovery. While they are completely unconscious during the "intraoperative period" and won't remember the fentanyl being administered, the dosage chosen by the team dictates how smoothly they wake up.

OR and PACU Clinicians and Nurses (Anesthesiologists, CRNAs, Circulating Nurses). Team inherits the results of this intraoperative and postoperative tracking during the handoff report. When they receive the patient, they look at the total mean fentanyl rate administered in the OR to anticipate the patient's immediate post-op needs.

Participant Group/Arms

Control GroupActive Comparator

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.

Procedure: Standard

Intervention GroupExperimental

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%.

Procedure: EEG-guided