Application of Esketamine in Anesthesia of Autism Children

NCT05960942 | Completed

• 1 other identifier: esketamine 2023 N001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

fecal Microbiota Transplantation; transendoscopic enteral tube; Gut microbiota; anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• degree of emergence agitation

  Up to 2 hour after the procedure

• time to full recovery

  Up to 3 hour after the procedure

• arterial blood pressure

  through study completion, an average of 15 minutes

• adverse event

  Up to 24 hour after the procedure

Study Arms (2)

propofol-esketamine

EXPERIMENTAL

Drug: propofol combined with esketamine

propofol-sufentanil

ACTIVE COMPARATOR

Drug: propofol-sufentanil

Interventions

propofol combined with esketamine DRUG

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.

propofol-esketamine

propofol-sufentanil DRUG

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.

propofol-sufentanil

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Nanjing Medical University: collaborator

Study Sites (1)

Sir Run Run Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-07

Locations

CN (1)