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Clinical trial

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

ID
Name
esketamine 2023 N001
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2023-10-30
Trial end
2023-10-30
Status
Completed
Treatment
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.
Arms:
propofol-esketamine
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.
Arms:
propofol-sufentanil
Size
120
Primary endpoint
movement score during the procedure
through study completion, an average of 10 minutes
first movement time
Up to 1 hour after the procedure
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-10-31

1 organization

2 products

1 indication

Organization
The Second Hospital of Nanjing Medical University
Product
Propofol + Esketamine
Indication
Autism Spectrum Disorder
Product
propofol-sufentanil