Application of Esketamine in Anesthesia of Autism Children

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: propofol combined with esketamine; Drug: propofol-sufentanil

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Sir Run Run Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
arterial blood pressure	arterial blood pressure was measured noninvasively	through study completion, an average of 15 minutes
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

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Collaborators: SIR RUN RUN hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: anaesthesia; Gut microbiota; fecal Microbiota Transplantation; transendoscopic enteral tube
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Adjuvants, Anesthesia; Propofol; Esketamine; Sufentanil
• Other Study ID Numbers: esketamine 2023 N001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No