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

NCT ID: NCT05210764

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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General Anesthetic Electroencephalogram

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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propofol

General anesthesia is induced and maintained mainly with propofol.

propofol

Intervention Type DRUG

General anesthesia is induced and maintained mainly with propofol.

sevoflurane

General anesthesia is induced and maintained mainly with sevoflurane.

sevoflurane

Intervention Type DRUG

General anesthesia is induced and maintained mainly with sevoflurane.

ketamine

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

S-ketamine

Intervention Type DRUG

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

Interventions

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propofol

General anesthesia is induced and maintained mainly with propofol.

Intervention Type DRUG

sevoflurane

General anesthesia is induced and maintained mainly with sevoflurane.

Intervention Type DRUG

S-ketamine

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

Intervention Type DRUG

Other Intervention Names

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Propofol anesthesia group Sevoflurane anesthesia group S-ketamine anesthesia group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Xin Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Xin Wang, MD, PhD

Role: STUDY_DIRECTOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Linlin Song, MD

Role: CONTACT

86-13501309217

Facility Contacts

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Lin-Lin no Song, MD

Role: primary

86-010-83575138

Other Identifiers

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2022-01-08

Identifier Type: -

Identifier Source: org_study_id

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