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

Sponsor
Peking University First Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05210764
Collaborator
(none)
90
Enrollment
26
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. phase-amplitude coupling [induction and maintenance of anesthesia]

      phase-amplitude coupling

    2. bicoherence [induction and maintenance of anesthesia]

      bicoherence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children aged 3-7 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;

    • Operation duration of <20min or >2h;

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University First Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-Xin Wang, Professor, Peking University First Hospital
    ClinicalTrials.gov Identifier:
    NCT05210764
    Other Study ID Numbers:
    • 2022-01-08
    First Posted:
    Jan 27, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dong-Xin Wang, Professor, Peking University First Hospital
    general anesthetic
    electroencephalogram
    Additional relevant MeSH terms:
    Ketamine
    Anesthetics
    Propofol
    Sevoflurane
    Esketamine

    Study Results

    No Results Posted as of Apr 20, 2022