Application of Esketamine in Anesthesia of Autism Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Esketamine in Anesthesia of Autism Children Undergoing Colonic Transendoscopic Enteral Tubing

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: propofol combined with esketamine
* Drug: propofol-sufentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol-esketamine<br> | Drug: propofol combined with esketamine<br>* 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.<br>|
| Active Comparator: propofol-sufentanil<br> | Drug: propofol-sufentanil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| movement score during the procedure | (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure) | through study completion, an average of 10 minutes | 
| first movement time | the time from arriving Postanesthesia care unit to first gross limb movement after procedure | Up to 1 hour after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 2 hour after the procedure | 
| time to full recovery | achieve modified Aldrete score of 10 with the vital signs being normal and stable | Up to 3 hour after the procedure | 
| arterial blood pressure | arterial blood pressure was measured noninvasively | through study completion, an average of 15 minutes | 
| 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. | Up to 24 hour after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal Microbiota Transplantation, transendoscopic enteral tube, Gut microbiota, anaesthesia