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Pediatric AnesthesiaNCT07714785

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

A study testing EEG-guided and Standard in people with Pediatric Anesthesia and Emergence Delirium, Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 8 years
What is being tested?
EEG-guided and Standard
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChile
Study dates
23 Jun 2026to 25 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 2-8 years
  • ASA Physical Status I or II
  • Elective tonsillectomy (±adenoidectomy)
  • Signed parental consent (and assent ≥7 years)

Who cannot join

  • Neurological or psychiatric disorders
  • Growth or developmental delay
  • Known allergy to study medications
  • Coagulation disorders
  • Parental or patient refusal

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital UC Christus

    Santiago, Región, 450881

Other trials in Chile

About this study

Official title: 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.

Read the 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.

Being tested
EEG-guided, Standard
Keywords
Sevoflurano, Pediatric Anesthesia, Tonsillectomy, Electroencephalogram
Medical subject headings
Emergence Delirium, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEG-guidedProcedure or surgery

    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%.

  • StandardProcedure or surgery

    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.

Study groups in NCT07714785
Study groupRoleWhat they receive
Control GroupActive comparatorInduction 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.
Receives: Procedure: Standard
Intervention GroupExperimentalInduction 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%.
Receives: Procedure: EEG-guided

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total intraoperative opioid consumption

    Mean fentanyl rate (mcg/kg).

    Measured: Intraoperative period

Secondary outcomes (15)

  1. Sevoflurane exposure

    Age-adjusted MAC-hours

    Measured: Intraoperative period

  2. Sevoflurane exposure

    EtSevo

    Measured: Intraoperative period

  3. EEG burst suppression

    incidence

    Measured: Intraoperative period

  4. EEG spectral markers_TBP

    Total band power

    Measured: Intraoperative period

  5. EEG spectral markers_MedF

    Median frequency

    Measured: Intraoperative period

  6. EEG spectral markers_SEF95

    SEF 95%

    Measured: Intraoperative period

  7. EEG burst suppression

    Cumulative duration

    Measured: Intraoperative period

  8. hemodynamic, Bradicardia

    Intraoperative bradycardia (HR<20% basaline) requiring intervention

    Measured: Intraoperative period

  9. hemodynamic, hypotension

    intraoperative hypotension (MAP<20% basaline) requiring intervention

    Measured: Intraoperative period

  10. emergence time

    Time from anesthesia discontinuation to extubation

    Measured: From end of anesthesia period to extubation

  11. Eye opening, emergence time

    Time from anesthesia discontinuation to eye opening

    Measured: From end of anesthesia period to extubation

  12. emergence delirium

    incidence by paed scale

    Measured: Post anesthesia period

  13. Postoperative pain

    flacc/vas scores

    Measured: Post anesthesia period

  14. Rescue analgesia

    Drug use for rescue analgesia non opioids (mg)

    Measured: Post anesthesia period

  15. postoperative opioid use

    fentanyl use for pain rescue (mcg)

    Measured: Post anesthesia period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start23 Jun 2026
  3. Primary completion25 Aug 2026
  4. Study completion25 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Assignment 1:1
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07714785
Sponsor's protocol ID
260319004
Status last verified
Sep 2026
First submitted
23 Jun 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report

Publications

  • 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.

    PubMed 40257811

  • 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.

    PubMed 34481361

  • 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.

    PubMed 32224720

Questions about this trial

What is this clinical trial studying?

A study testing EEG-guided and Standard in people with Pediatric Anesthesia and Emergence Delirium, Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total intraoperative opioid consumption (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07714785, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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