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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
120
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.
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.
Sir Run Run Hospital
Nanjing, China
movement score during the procedure
(1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
Time frame: 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
Time frame: Up to 1 hour after the procedure
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
Time frame: 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
Time frame: Up to 3 hour after the procedure
arterial blood pressure
arterial blood pressure was measured noninvasively
Time frame: 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.
Time frame: Up to 24 hour after the procedure
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