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| Name | Class |
|---|---|
| Nanjing Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol-esketamine | Experimental |
| |
| propofol-sufentanil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol combined with esketamine | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Hospital | Nanjing | China |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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| propofol-sufentanil | Drug | 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. |
|
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 |