Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Determination of the Median Effective Dose of Propofol in Combination With Different Doses of Esketamine During Colonoscopy for Children With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Esketamine
* Drug: Esketamine
* Drug: Propofol


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 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eskatemine 0.3mg/kg + propofol<br>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. | Drug: Esketamine<br>* esketamine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.<br>Drug: Propofol<br>* propofol<br>|
| Experimental: eskatemine 0.6mg/kg + propofol<br>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. | Drug: Esketamine<br>* 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.<br>Drug: Propofol<br>* propofol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1 | 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. | Procedure (This outcome is measured at the time of insertion of colonoscopy) | 
| Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2 | 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. | Procedure (This outcome is measured at the time of insertion of colonoscopy) | 

Secondary 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) | during the procudure | 
| arterial blood pressure | 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。 | during the procudure | 
| adverse event | (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. | during the procedure - 24 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, anaesthesia, autism spectrum disorder, propofol, esketamine