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

4. september 2026 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Eksperimentell: 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%.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. juni 2026

Primær fullføring (Faktiske)

25. august 2026

Studiet fullført (Faktiske)

25. august 2026

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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