- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07714785
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
Studieoversikt
Status
Intervensjon / Behandling
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Región
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Santiago, Región, Chile, 450881
- Hospital UC Christus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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.
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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.
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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%.
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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%.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total intraoperative opioid consumption
Tidsramme: Intraoperative period
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Mean fentanyl rate (mcg/kg).
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Intraoperative period
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sevoflurane exposure
Tidsramme: Intraoperative period
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Age-adjusted MAC-hours
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Intraoperative period
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Sevoflurane exposure
Tidsramme: Intraoperative period
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EtSevo
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Intraoperative period
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EEG burst suppression
Tidsramme: Intraoperative period
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incidence
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Intraoperative period
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EEG spectral markers_TBP
Tidsramme: Intraoperative period
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Total band power
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Intraoperative period
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EEG spectral markers_MedF
Tidsramme: Intraoperative period
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Median frequency
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Intraoperative period
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EEG spectral markers_SEF95
Tidsramme: Intraoperative period
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SEF 95%
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Intraoperative period
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EEG burst suppression
Tidsramme: Intraoperative period
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Cumulative duration
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Intraoperative period
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hemodynamic, Bradicardia
Tidsramme: Intraoperative period
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Intraoperative bradycardia (HR<20% basaline) requiring intervention
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Intraoperative period
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hemodynamic, hypotension
Tidsramme: Intraoperative period
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intraoperative hypotension (MAP<20% basaline) requiring intervention
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Intraoperative period
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emergence time
Tidsramme: From end of anesthesia period to extubation
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Time from anesthesia discontinuation to extubation
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From end of anesthesia period to extubation
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Eye opening, emergence time
Tidsramme: From end of anesthesia period to extubation
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Time from anesthesia discontinuation to eye opening
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From end of anesthesia period to extubation
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emergence delirium
Tidsramme: Post anesthesia period
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incidence by paed scale
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Post anesthesia period
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Postoperative pain
Tidsramme: Post anesthesia period
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flacc/vas scores
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Post anesthesia period
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Rescue analgesia
Tidsramme: Post anesthesia period
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Drug use for rescue analgesia non opioids (mg)
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Post anesthesia period
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postoperative opioid use
Tidsramme: Post anesthesia period
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fentanyl use for pain rescue (mcg)
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Post anesthesia period
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Victor Contreras, MSN, RN, Researcher
- Hovedetterforsker: Mauricio Ibacache, Phd, Professor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Wang HY, Chen TY, Li DJ, Lin PY, Su KP, Chiang MH, Carvalho AF, Stubbs B, Tu YK, Wu YC, Roerecke M, Smith L, Tseng PT, Hung KC. Association of pharmacological prophylaxis with the risk of pediatric emergence delirium after sevoflurane anesthesia: An updated network meta-analysis. J Clin Anesth. 2021 Dec;75:110488. doi: 10.1016/j.jclinane.2021.110488. Epub 2021 Sep 1.
- Miyasaka KW, Suzuki Y, Brown EN, Nagasaka Y. EEG-Guided Titration of Sevoflurane and Pediatric Anesthesia Emergence Delirium: A Randomized Clinical Trial. JAMA Pediatr. 2025 Apr 21;179(7):704-12. doi: 10.1001/jamapediatrics.2025.0517. Online ahead of print.
- Sun Y, Ye F, Wang J, Ai P, Wei C, Wu A, Xie W. Electroencephalography-Guided Anesthetic Delivery for Preventing Postoperative Delirium in Adults: An Updated Meta-analysis. Anesth Analg. 2020 Sep;131(3):712-719. doi: 10.1213/ANE.0000000000004746.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Forvirring
- Nevroatferdsmanifestasjoner
- Nevrokognitive lidelser
- Delirium
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Emergence Delirium
- Smerter, postoperativt
Andre studie-ID-numre
- 260319004
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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