NCT07714785

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Jan 2028

First Submitted

Initial submission to the registry

June 23, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 23, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

June 23, 2026

Last Update Submit

July 21, 2026

Conditions

Pediatric AnesthesiaEmergence Delirium, AnesthesiaPostoperative PainTonsillectomy

Keywords

SevofluranoPediatric AnesthesiaTonsillectomyElectroencephalogram

Outcome Measures

Primary Outcomes (1)

  • Total intraoperative opioid consumption

    Mean fentanyl rate (mcg/kg).

    Intraoperative period

Secondary Outcomes (15)

  • Sevoflurane exposure

    Intraoperative period

  • Sevoflurane exposure

    Intraoperative period

  • EEG burst suppression

    Intraoperative period

  • EEG spectral markers_TBP

    Intraoperative period

  • EEG spectral markers_MedF

    Intraoperative period

  • +10 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Procedure: Standard

Intervention Group

EXPERIMENTAL

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%.

Procedure: EEG-guided

Interventions

EEG-guidedPROCEDURE

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%.

Intervention Group
StandardPROCEDURE

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.

Control Group

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital UC Christus

Santiago, Región, 450881, Chile

RECRUITING

Related Publications (3)

  • 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.

    PMID: 40257811BACKGROUND

  • 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.

    PMID: 34481361BACKGROUND

  • 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.

    PMID: 32224720BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumPain, Postoperative

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersPain

Study Officials

  • Victor Contreras, MSN, RN

    Researcher

    STUDY CHAIR

  • Mauricio Ibacache, Phd

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauricio Ibacache, Phd

CONTACT

+56984421425mianesteman@gmail.com

Ricardo Fuentes, MD

CONTACT

+56984421425rfuente@ucchristus.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The Participant (Patient). From the patient's point of view, this metric directly impacts their comfort, safety, and recovery. While they are completely unconscious during the "intraoperative period" and won't remember the fentanyl being administered, the dosage chosen by the team dictates how smoothly they wake up. OR and PACU Clinicians and Nurses (Anesthesiologists, CRNAs, Circulating Nurses). Team inherits the results of this intraoperative and postoperative tracking during the handoff report. When they receive the patient, they look at the total mean fentanyl rate administered in the OR to anticipate the patient's immediate post-op needs.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Assignment 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 20, 2026

Study Start

June 23, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

CL(1)