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

4. september 2026 opdateret af: Pontificia Universidad Catolica de Chile

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

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Región
      • Santiago, Región, Chile, 450881
        • Hospital UC Christus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Group
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.
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.
Eksperimentel: Intervention Group
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%.
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%.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total intraoperative opioid consumption
Tidsramme: Intraoperative period
Mean fentanyl rate (mcg/kg).
Intraoperative period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sevoflurane exposure
Tidsramme: Intraoperative period
Age-adjusted MAC-hours
Intraoperative period
Sevoflurane exposure
Tidsramme: Intraoperative period
EtSevo
Intraoperative period
EEG burst suppression
Tidsramme: Intraoperative period
incidence
Intraoperative period
EEG spectral markers_TBP
Tidsramme: Intraoperative period
Total band power
Intraoperative period
EEG spectral markers_MedF
Tidsramme: Intraoperative period
Median frequency
Intraoperative period
EEG spectral markers_SEF95
Tidsramme: Intraoperative period
SEF 95%
Intraoperative period
EEG burst suppression
Tidsramme: Intraoperative period
Cumulative duration
Intraoperative period
hemodynamic, Bradicardia
Tidsramme: Intraoperative period
Intraoperative bradycardia (HR<20% basaline) requiring intervention
Intraoperative period
hemodynamic, hypotension
Tidsramme: Intraoperative period
intraoperative hypotension (MAP<20% basaline) requiring intervention
Intraoperative period
emergence time
Tidsramme: From end of anesthesia period to extubation
Time from anesthesia discontinuation to extubation
From end of anesthesia period to extubation
Eye opening, emergence time
Tidsramme: From end of anesthesia period to extubation
Time from anesthesia discontinuation to eye opening
From end of anesthesia period to extubation
emergence delirium
Tidsramme: Post anesthesia period
incidence by paed scale
Post anesthesia period
Postoperative pain
Tidsramme: Post anesthesia period
flacc/vas scores
Post anesthesia period
Rescue analgesia
Tidsramme: Post anesthesia period
Drug use for rescue analgesia non opioids (mg)
Post anesthesia period
postoperative opioid use
Tidsramme: Post anesthesia period
fentanyl use for pain rescue (mcg)
Post anesthesia period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Victor Contreras, MSN, RN, Researcher
  • Ledende efterforsker: Mauricio Ibacache, Phd, Professor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. juni 2026

Primær færdiggørelse (Faktiske)

25. august 2026

Studieafslutning (Faktiske)

25. august 2026

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. september 2026

Mere information

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Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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