Clinical trial NCT05960942: Application of Esketamine in Anesthesia of Autism Children
Official title: Application of Esketamine in Anesthesia of Autism Children Undergoing Colonic Transendoscopic Enteral Tubing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: fecal Microbiota Transplantation
transendoscopic enteral tube
Gut microbiota
anaesthesia
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
First posted: 2023-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: movement score during the procedure
timeFrame: through study completion, an average of 10 minutes
measure: first movement time
timeFrame: Up to 1 hour after the procedure
Secondary outcomes:
measure: degree of emergence agitation
timeFrame: Up to 2 hour after the procedure
measure: time to full recovery
timeFrame: Up to 3 hour after the procedure
measure: arterial blood pressure
timeFrame: through study completion, an average of 15 minutes
measure: adverse event
timeFrame: Up to 24 hour after the procedure
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Sir Run Run Hospital
Study officials:
References: