Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2023-09-20

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.

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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eskatemine 0.3mg/kg + propofol

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

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.

Propofol

Intervention Type DRUG

propofol

eskatemine 0.6mg/kg + propofol

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type 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

Intervention Type DRUG

propofol

Interventions

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Esketamine

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.

Intervention Type DRUG

Esketamine

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.

Intervention Type DRUG

Propofol

propofol

Intervention Type DRUG

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No