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

NCT05210764 | Recruiting

• 1 other identifier: 2022-01-08
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

General Anesthetic; Electroencephalogram

Keywords

general anesthetic; electroencephalogram

Outcome Measures

Primary Outcomes (4)

• phase-amplitude coupling

  phase-amplitude coupling

  induction, maintenance, and recovery of anesthesia

• bicoherence

  bicoherence

  induction and maintenance, and recovery of anesthesia

• spectral analysis

  spectral analysis

  induction and maintenance, and recovery of anesthesia

• entropy indices

  entropy indices

  induction and maintenance, and recovery of anesthesia

Study Arms (3)

propofol

General anesthesia is induced and maintained mainly with propofol.

Drug: propofol

sevoflurane

General anesthesia is induced and maintained mainly with sevoflurane.

Drug: sevoflurane

ketamine

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

Drug: S-ketamine

Interventions

propofol DRUG

General anesthesia is induced and maintained mainly with propofol.

Also known as: Propofol anesthesia group

propofol

sevoflurane DRUG

General anesthesia is induced and maintained mainly with sevoflurane.

Also known as: Sevoflurane anesthesia group

sevoflurane

S-ketamine DRUG

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

Also known as: S-ketamine anesthesia group

ketamine

Eligibility Criteria

• Age: 1 Minute - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Propofol; Sevoflurane; Esketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Linlin Song, MD

CONTACT

86-13501309217; songlinlinlynkia@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 27, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)