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NCT Number: NCT07714785

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

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.

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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital UC Christus

Santiago, Región, 450881, Chile

Location status: Recruiting

Location contact

Felipe Yañez, MD

SUB_INVESTIGATOR

Francisco Cruzat, MD

SUB_INVESTIGATOR

Karen Azagra, TM

SUB_INVESTIGATOR

Luis I Cortinez, MD

SUB_INVESTIGATOR

Mauricio Ibacache, Phd

CONTACT

[email protected]

+56 9 8442 1425

Sebastian Fuentes, MD

SUB_INVESTIGATOR

Victor Contreras, MSN, RN

CONTACT

[email protected]

56981895232

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG-guided

Procedure

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%.

standard

Procedure

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.

Primary outcomes

  1. Total intraoperative opioid consumption

    Time frame: Intraoperative period

    Mean fentanyl rate (mcg/kg).

Secondary outcomes

  1. Sevoflurane exposure

    Time frame: Intraoperative period

    Age-adjusted MAC-hours

  2. Sevoflurane exposure

    Time frame: Intraoperative period

    EtSevo

  3. EEG burst suppression

    Time frame: Intraoperative period

    incidence

  4. EEG spectral markers_TBP

    Time frame: Intraoperative period

    Total band power

  5. EEG spectral markers_MedF

    Time frame: Intraoperative period

    Median frequency

  6. EEG spectral markers_SEF95

    Time frame: Intraoperative period

    SEF 95%

  7. EEG burst suppression

    Time frame: Intraoperative period

    Cumulative duration

  8. hemodynamic, Bradicardia

    Time frame: Intraoperative period

    Intraoperative bradycardia (HR<20% basaline) requiring intervention

  9. hemodynamic, hypotension

    Time frame: Intraoperative period

    intraoperative hypotension (MAP<20% basaline) requiring intervention

  10. emergence time

    Time frame: From end of anesthesia period to extubation

    Time from anesthesia discontinuation to extubation

  11. Eye opening, emergence time

    Time frame: From end of anesthesia period to extubation

    Time from anesthesia discontinuation to eye opening

  12. emergence delirium

    Time frame: Post anesthesia period

    incidence by paed scale

  13. Postoperative pain

    Time frame: Post anesthesia period

    flacc/vas scores

  14. Rescue analgesia

    Time frame: Post anesthesia period

    Drug use for rescue analgesia non opioids (mg)

  15. postoperative opioid use

    Time frame: Post anesthesia period

    fentanyl use for pain rescue (mcg)

Study contacts

Contact information is provided by the study sponsor or research team.

Mauricio Ibacache, Phd

CONTACT

[email protected]

+56984421425

Ricardo Fuentes, MD

CONTACT

[email protected]

+56984421425

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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