Skip to main content
OpenTrials
Completed

NCT Number: NCT05960942

Application of Esketamine in Anesthesia of Autism Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Hospital

Nanjing, China

About this study

Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. The participants 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 primary objective was to compare the clinical efficacy and safety of propofol-esketamine (PE) with propofol-sufentanil (PS) for deep sedation in the procedure of colonic TET in ASD children. A secondary objective was to compare adverse events (AEs) and recovery in those children during/after either PE or PS sedation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 TET 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.

Treatment and study plan

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-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.

Primary outcomes

  1. movement score during the procedure

    Time frame: through study completion, an average of 10 minutes

    (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)

  2. first movement time

    Time frame: Up to 1 hour after the procedure

    the time from arriving Postanesthesia care unit to first gross limb movement after procedure

Secondary outcomes

  1. degree of emergence agitation

    Time frame: Up to 2 hour after the procedure

    1 = calm; 2 = not calm but could be easily calmed; 3 = not easily calmed, moderately agitated or restless; and 4 = combative, excited, or disoriented, trashing around

  2. time to full recovery

    Time frame: Up to 3 hour after the procedure

    achieve modified Aldrete score of 10 with the vital signs being normal and stable

  3. arterial blood pressure

    Time frame: through study completion, an average of 15 minutes

    arterial blood pressure was measured noninvasively

  4. adverse event

    Time frame: Up to 24 hour after the procedure

    (including hypoxia (SpO2 <93% for >10 seconds) or respiratory depression (apnea >15 seconds), hypotension (mean arterial pressure < 20% from baseline) or bradycardia (heart rate < 60 /min and/or decrease in heart rate > 20% from baseline) were recorded.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Nanjing Medical University

Registry information

Official study title

Application of Esketamine in Anesthesia of Autism Children Undergoing Colonic Transendoscopic Enteral Tubing

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.