Autism Spectrum Disorder
Conditions
Keywords
fecal Microbiota Transplantation, transendoscopic enteral tube, Gut microbiota, anaesthesia
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.
Interventions
DRUGpropofol 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.
DRUGpropofol-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.
Sponsors
Nanjing Medical University
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed