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Clinical trial

Determination of the Median Effective Dose of Propofol in Combination With Different Doses of Esketamine During Colonoscopy for Children With Autism Spectrum Disorder

ID
Name
esketamine 2023 N002
Description
The purpose of this study is to examine the dose-response relationship of esketamine in combination with propofol for children with Autism Spectrum Disorder undering colonoscopy.
Trial arms
Trial start
2023-07-20
Estimated PCD
2023-09-20
Trial end
2023-09-20
Status
Completed
Treatment
Esketamine
esketamine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Arms:
eskatemine 0.3mg/kg + propofol
Esketamine
esketamine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Arms:
eskatemine 0.6mg/kg + propofol
Propofol
propofol
Arms:
eskatemine 0.3mg/kg + propofol, eskatemine 0.6mg/kg + propofol
Size
46
Primary endpoint
Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1
Procedure (This outcome is measured at the time of insertion of colonoscopy)
Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2
Procedure (This outcome is measured at the time of insertion of colonoscopy)
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 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': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2023-10-10

1 organization

2 products

1 indication

Organization
The Second Hospital of Nanjing Medical University
Product
Esketamine
Indication
Autism Spectrum Disorder
Product
Propofol