Application of Esketamine in Anesthesia of Autism Children

Sponsor

The Second Hospital of Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05960942

Collaborator

SIR RUN RUN hospital of Nanjing Medical University (Other)

Enrollment

Arms

5.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Drug: propofol combined with esketamine Drug: propofol-sufentanil	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: propofol-esketamine	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.
Active Comparator: propofol-sufentanil	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.

Arm

Intervention/Treatment

Experimental: propofol-esketamine

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.

Active Comparator: propofol-sufentanil

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.

Outcome Measures

Primary Outcome Measures

movement score during the procedure [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)
first movement time [Up to 1 hour after the procedure]
the time from arriving Postanesthesia care unit to first gross limb movement after procedure

Secondary Outcome Measures

degree of emergence agitation [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
time to full recovery [Up to 3 hour after the procedure]
achieve modified Aldrete score of 10 with the vital signs being normal and stable
arterial blood pressure [through study completion, an average of 15 minutes]
arterial blood pressure was measured noninvasively
adverse event [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.