NCT05960942

Application of Esketamine in Anesthesia of Autism Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	propofol combined with esketamine	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.
DRUG	propofol-sufentanil	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2023-07-27
• Last updated: 2023-10-31

Locations

1 site across 1 country: China