Application of Esketamine in Anesthesia of Autism Children

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05960942
• Other study ID #: esketamine 2023 N001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2023
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sir Run Run Hospital	Nanjing

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	SIR RUN RUN hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	degree of emergence agitation	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	Up to 2 hour after the procedure
Secondary	time to full recovery	achieve modified Aldrete score of 10 with the vital signs being normal and stable	Up to 3 hour after the procedure
Secondary	arterial blood pressure	arterial blood pressure was measured noninvasively	through study completion, an average of 15 minutes
Secondary	adverse event	(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.	Up to 24 hour after the procedure