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Application of Esketamine in Anesthesia of Autism Children

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
propofol combined with esketamine
propofol-sufentanil
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring fecal Microbiota Transplantation, transendoscopic enteral tube, Gut microbiota, anaesthesia

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    propofol-esketamine

    propofol-sufentanil

    Arm Description

    Outcomes

    Primary Outcome Measures

    movement score during the procedure
    (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
    first movement time
    the time from arriving Postanesthesia care unit to first gross limb movement after procedure

    Secondary Outcome Measures

    degree of emergence agitation
    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
    time to full recovery
    achieve modified Aldrete score of 10 with the vital signs being normal and stable
    arterial blood pressure
    arterial blood pressure was measured noninvasively
    adverse event
    (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.

    Full Information

    First Posted
    May 25, 2023
    Last Updated
    July 17, 2023
    Sponsor
    The Second Hospital of Nanjing Medical University
    Collaborators
    SIR RUN RUN hospital of Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960942
    Brief Title
    Application of Esketamine in Anesthesia of Autism Children
    Official Title
    Application of Esketamine in Anesthesia of Autism Children Undergoing Colonic Transendoscopic Enteral Tubing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 20, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Second Hospital of Nanjing Medical University
    Collaborators
    SIR RUN RUN hospital of Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    fecal Microbiota Transplantation, transendoscopic enteral tube, Gut microbiota, anaesthesia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    propofol-esketamine
    Arm Type
    Experimental
    Arm Title
    propofol-sufentanil
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    propofol combined with esketamine
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    propofol-sufentanil
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    movement score during the procedure
    Description
    (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
    Time Frame
    through study completion, an average of 10 minutes
    Title
    first movement time
    Description
    the time from arriving Postanesthesia care unit to first gross limb movement after procedure
    Time Frame
    Up to 1 hour after the procedure
    Secondary Outcome Measure Information:
    Title
    degree of emergence agitation
    Description
    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
    Time Frame
    Up to 2 hour after the procedure
    Title
    time to full recovery
    Description
    achieve modified Aldrete score of 10 with the vital signs being normal and stable
    Time Frame
    Up to 3 hour after the procedure
    Title
    arterial blood pressure
    Description
    arterial blood pressure was measured noninvasively
    Time Frame
    through study completion, an average of 15 minutes
    Title
    adverse event
    Description
    (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.
    Time Frame
    Up to 24 hour after the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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