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

July 28, 2025 updated by: Dong-Xin Wang, Peking University First Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

366

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
propofol
General anesthesia is induced and maintained mainly with propofol.
Drug: propofol
General anesthesia is induced and maintained mainly with propofol.
Other Names:
  • Propofol anesthesia group
sevoflurane
General anesthesia is induced and maintained mainly with sevoflurane.
Drug: sevoflurane
General anesthesia is induced and maintained mainly with sevoflurane.
Other Names:
  • Sevoflurane anesthesia group
ketamine
General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.
Drug: S-ketamine
General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.
Other Names:
  • S-ketamine anesthesia group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
phase-amplitude coupling
Time Frame: induction, maintenance, and recovery of anesthesia
phase-amplitude coupling
induction, maintenance, and recovery of anesthesia
bicoherence
Time Frame: induction and maintenance, and recovery of anesthesia
bicoherence
induction and maintenance, and recovery of anesthesia
spectral analysis
Time Frame: induction and maintenance, and recovery of anesthesia
spectral analysis
induction and maintenance, and recovery of anesthesia
entropy indices
Time Frame: induction and maintenance, and recovery of anesthesia
entropy indices
induction and maintenance, and recovery of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Study Director: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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