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Recruiting NCT05210764

General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia

Observational General Anesthetic Electroencephalogram

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: propofol, sevoflurane, S-ketamine.
Who it may be relevant to
Registry conditions: General Anesthetic, Electroencephalogram. Basic parameters: 1 Minute — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

Detailed description

The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

Interventions

  • Drug propofol
    General anesthesia is induced and maintained mainly with propofol.
  • Drug sevoflurane
    General anesthesia is induced and maintained mainly with sevoflurane.
  • Drug S-ketamine
    General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.

Primary outcome measures

  • phase-amplitude coupling [Time frame: induction, maintenance, and recovery of anesthesia]
  • bicoherence [Time frame: induction and maintenance, and recovery of anesthesia]
  • spectral analysis [Time frame: induction and maintenance, and recovery of anesthesia]
  • entropy indices [Time frame: induction and maintenance, and recovery of anesthesia]

Eligibility criteria

Inclusion criteria

  • patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.

Exclusion criteria

  • Preterm patients;
  • Height and weight not within the standard ranges for respective ages;
  • Surgery for head or heart;
  • Patients with muscular, neurologic or psychiatric diseases;
  • Patients with Congenital anomaly or hereditary diseases;
  • Patients with medication abuse;
  • Allergy to medication including propofol, sevoflurane, and ketamine;
  • Allergy to beans;
  • Refusal to participate the study by guardians.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Publications

  • Zhang Y, Liang ZH, Wang X, Zhang N, Zhu HT, Wang DX, Guo XY, Li XL, Song LL. Age-Dependent Entropic Features During Propofol Anesthesia in Developing Brain. Anesth Analg. 2026 Apr 1;142(4):769-781. doi: 10.1213/ANE.0000000000007608. Epub 2025 Jul 10. PMID 40638527

Identifiers

NCT: NCT05210764 · 2022-01-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗