Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Nanjing Medical University

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Drug: Esketamine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05951465

esketamine 2023 N002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

eskatemine 0.3mg/kg + propofol

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: Esketamine

Drug: Esketamine

eskatemine 0.6mg/kg + propofol

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: Esketamine

Drug: Esketamine