Application of Esketamine in Anesthesia of Autism Children

NCT ID: NCT05960942

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-10-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

propofol-esketamine

Group Type: EXPERIMENTAL

propofol combined with esketamine

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

propofol-sufentanil

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sir Run Run Hospital

Nanjing, , China

Countries

China

Other Identifiers

esketamine 2023 N001

Identifier Type: -

Identifier Source: org_study_id