Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Brief Summary

The purpose of this study is to examine the dose-response relationship of esketamine in combination with propofol for children with Autism Spectrum Disorder undering colonoscopy.

Intervention / Treatment

  • Esketamine (DRUG)
    esketamine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
  • Propofol (DRUG)
    propofol

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: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Jul 30, 2023 ESTIMATED
    Primary Completion: Jan 01, 2024 ESTIMATED
    Completion Date: Jan 01, 2024 ESTIMATED
    Study First Posted: Jul 19, 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. They 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 colonoscopic procedure in autism children. Propofol sedation for endoscopic procedures is safe and acceptable for children, especially those who express significant anxiety. Propofol-based sedation turned out to be the most effective dosage regimens, with effectiveness comparable to general anesthesia. The addition of certain dose ketamine to propofol may increase the effectiveness without creating more adverse events.

    Participant Groups

    • eskatemine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.

    • eskatemine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.

    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 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

    • The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.

    • The objective is to determine the effective bolus dose in 95% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.

    Secondary Outcomes

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

    • arterial blood pressure was measured noninvasively at four time points:T0: before induction of sedation,T1: immediately after induction of sedation, T2: complete evaluation of the coln through colonoscopy, T3: at the end of colonic TET procedure。

    • (including hypoxia (SpO2 \<93% for \>10 s) or respiratory depression (apnea \>15 s), hypotension (MAP \< 20% from baseline) or bradycardia (HR \< 60 x/min and/or decrease in HR \> 20% from baseline) were recorded.

    More Details

    NCT Number: NCT05951465
    Other IDs: esketamine 2023 N002
    Study URL: https://clinicaltrials.gov/study/NCT05951465
    Last updated: Sep 29, 2023