Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Phase

N/A

Condition

Autism

Asperger's Disorder

Autism Spectrum Disorder (Asd)

Treatment

Esketamine

Propofol

Clinical Study ID

NCT05951465

esketamine 2023 N002

Ages 3-14
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

（1) aged 2-12 years;
(2) diagnosed with ASD by pediatric psychiatrists in accordance with the criteria inthe 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

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 notsuitable for participation in the clinical trial.

Study Design

Esketamine

July 20, 2023

September 20, 2023

Study Description

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.

Connect with a study center

Sir Run Run Hospital
Nanjing, Jiangsu 210000
China
Site Not Available

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