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Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children

Sponsor
Second Affiliated Hospital of Nanchang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079710
Collaborator
(none)
100
Enrollment
1
Location
1.9
Anticipated Duration (Months)
51.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Jiangxi Provincial Children's Hospital
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Emergence agitation group
    Non emergence agitation group

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of emergence agitation [The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours]

      The level of postoperative emergence agitation (EA) was assessed using the pediatric anesthesia emergence delirium Scale (PAED) and the emergence agitation 5 Scale immediately after extubation, and then every 15 min until the child was returned to the ward. emergence agitation was defined as a PAED score of ≥12 or a emergence agitation 5 scale of >3.

    Secondary Outcome Measures

    1. emergence time [Approximately 5 min-2 hours]

      The period of time between the cessation of the use of anesthetic drugs and the recovery of the child's autonomous consciousness and the ability to respond correctly to external stimuli.

    2. Postoperative pain intensity [The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours]

      Immediately after postoperative recovery, assess the pain intensity of the child using the FLACC pain scale, and then evaluate again every 15 minutes until the child leaves the recovery room. FLACC is divided into 0-10 points

    3. Compatibility during anesthesia induction period [Anesthesia induction period, up to 2 minutes]

      The degree of cooperation between the patient and the doctor's instructions during anesthesia induction period. Using the Anesthesia Induction Cooperation Scale (ICC) for evaluation, the higher the ICC score, the worse the compatibility

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The age of the child is 1-10 years old, regardless of gender;

    2. ASA grading I to II;

    3. Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia

    Exclusion Criteria:

    1. Respiratory infection occurred within 1 week before surgery;

    2. Potential or existing contraindications to general anesthesia;

    3. Significant abnormalities in blood routine or biochemical indicators;

    4. Patients with cognitive function, mental illness, or neurodevelopmental delay;

    5. Unable to cooperate in completing the test, the child's guardian refused to participate;

    6. Other reasons why researchers believe it is not suitable to participate in this experiment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jiangxi Provincial Children's Hospital Nanchang Jiangxi Provincial China 330000

    Sponsors and Collaborators

    • Second Affiliated Hospital of Nanchang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fuzhou Hua, Chief Physician, Second Affiliated Hospital of Nanchang University
    ClinicalTrials.gov Identifier:
    NCT06079710
    Other Study ID Numbers:
    • 2023-EEG-children
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Emergence Delirium

    Study Results

    No Results Posted as of Oct 12, 2023