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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07714785
Enrollment
50
Registered
2026-07-20
Start date
2026-06-23
Completion date
2026-08-25
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Anesthesia, Pediatric Anesthesia, Postoperative Pain, Tonsillectomy

Keywords

Sevoflurano, Pediatric Anesthesia, Tonsillectomy, Electroencephalogram

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.

Detailed description

Electroencephalography (EEG)-guided anesthetic titration has demonstrated significant clinical benefits in both pediatric and adult patients. However, proprietary EEG-based indices widely used for monitoring anesthetic depth are affected by patient age and the specific anesthetic agent used, limiting their validity and generalizability. More recently, titrating anesthetics based on a specific interpretation of EEG waveforms and their oscillatory patterns observed on the spectrogram has gained popularity. Previous studies indicate that sevoflurane titration based on specific EEG waveforms and oscillatory patterns yields more substantial reductions in sevoflurane exposure than previously reported with proprietary EEG indices. Furthermore, reducing sevoflurane exposure decreases the incidence of EEG burst suppression, results in faster emergence times, and reduces emergence delirium. However, most of these benefits have been reported in the context of surgeries where intraoperative antinociception was provided via central or peripheral nerve blocks, in the absence of increased intraoperative analgesic and opioid requirements. It remains unclear whether the benefits associated with reduced sevoflurane exposure are also observed in surgeries where intraoperative antinociception cannot be provided through regional blocks. In such cases, antinociception depends primarily on the co-administration of inhaled anesthetics and opioids. Therefore, the clinical benefits of decreasing sevoflurane exposure via electroencephalographic guidance must be weighed against the side effects of higher perioperative opioid requirements. What will be the impact of strict titration of the hypnotic component using electroencephalography in a painful surgery, in terms of intraoperative opioid consumption and the quality of anesthetic emergence? It is hypothesized that to adjust the sevoflurane dose according to EEG targets in children undergoing surgeries where intraoperative antinociception cannot be provided via regional blocks will result in a reduction of sevoflurane requirements. However, a compensatory increase in intraoperative opioid consumption is expected to be observed, which could subsequently affect the quality and duration of the anesthetic recovery period.

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.

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

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.

Intervention model description

Assignment 1:1

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total intraoperative opioid consumptionIntraoperative periodMean fentanyl rate (mcg/kg).

Secondary

MeasureTime frameDescription
Sevoflurane exposureIntraoperative periodAge-adjusted MAC-hours
EEG burst suppressionIntraoperative periodincidence
EEG spectral markers_TBPIntraoperative periodTotal band power
EEG spectral markers_MedFIntraoperative periodMedian frequency
EEG spectral markers_SEF95Intraoperative periodSEF 95%
hemodynamic, BradicardiaIntraoperative periodIntraoperative bradycardia (HR\<20% basaline) requiring intervention
hemodynamic, hypotensionIntraoperative periodintraoperative hypotension (MAP\<20% basaline) requiring intervention
emergence timeFrom end of anesthesia period to extubationTime from anesthesia discontinuation to extubation
Eye opening, emergence timeFrom end of anesthesia period to extubationTime from anesthesia discontinuation to eye opening
emergence deliriumPost anesthesia periodincidence by paed scale
Postoperative painPost anesthesia periodflacc/vas scores
Rescue analgesiaPost anesthesia periodDrug use for rescue analgesia non opioids (mg)
postoperative opioid usePost anesthesia periodfentanyl use for pain rescue (mcg)

Countries

Chile

Contacts

STUDY_CHAIRVictor Contreras, MSN, RN

Researcher

PRINCIPAL_INVESTIGATORMauricio Ibacache, Phd

Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026