Application of Esketamine in Anesthesia of Autism Children

Brief Summary

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. Autistic children have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The investigators intend to explore an optimum anesthetic regimen for autism children undergoing endoscopic procedures.

Intervention / Treatment

  • propofol combined with esketamine (DRUG)
    In group PE, esketamine was firstly administered at a dose of 0.3 mg.kg-1, followed immediately by propofol with a single intravenous dose of 2.0 mg.kg-1.
  • propofol-sufentanil (DRUG)
    In group PS, sufentanil was administered intravenously at a dose of 0.2 μg.kg-1, then 2.0 mg.kg-1 propofol was intravenously injected.

Condition or Disease

  • Autism Spectrum Disorder

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 3 Years to 14 Years
    Enrollment: 50 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Other

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 20, 2023 ESTIMATED
    Primary Completion: Jan 01, 2024 ESTIMATED
    Completion Date: Jan 01, 2024 ESTIMATED
    Study First Posted: Jul 27, 2023 ACTUAL
    Last Updated: Jul 17, 2023

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Lead sponsor is responsible party
    Responsible Party: N/A

    Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. The participants have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The primary objective was to compare the clinical efficacy and safety of propofol-esketamine (PE) with propofol-sufentanil (PS) for deep sedation in the procedure of colonic TET in ASD children. A secondary objective was to compare adverse events (AEs) and recovery in those children during/after either PE or PS sedation.

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 14
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * (1) aged 2-12 years;
    * (2) diagnosed with ASD by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
    * (3) evaluated as American Society of Anesthesiologists (ASA) physical status I-II;
    * (4) scheduled for colonic TET procedure.

    Exclusion Criteria:

    * (1) oral sedation (premedication) before intravenous catheter placement;
    * (2) any contraindication to study medications;
    * (3) other circumstances in which the investigator determined that a patient was not suitable for participation in the clinical trial.

    Primary Outcomes

    • (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)

    • the time from arriving Postanesthesia care unit to first gross limb movement after procedure

    Secondary Outcomes

    • 1 = calm; 2 = not calm but could be easily calmed; 3 = not easily calmed, moderately agitated or restless; and 4 = combative, excited, or disoriented, trashing around

    • achieve modified Aldrete score of 10 with the vital signs being normal and stable

    • arterial blood pressure was measured noninvasively

    • (including hypoxia (SpO2 \<93% for \>10 seconds) or respiratory depression (apnea \>15 seconds), hypotension (mean arterial pressure \< 20% from baseline) or bradycardia (heart rate \< 60 /min and/or decrease in heart rate \> 20% from baseline) were recorded.

    More Details

    NCT Number: NCT05960942
    Other IDs: esketamine 2023 N001
    Study URL: https://clinicaltrials.gov/study/NCT05960942
    Last updated: Sep 29, 2023