An interventional study of Esketamine and Esketamine in Autism Spectrum Disorder, sponsored by The Second Hospital of Nanjing Medical University. Completed at 1 site in China. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. They 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 colonoscopic procedure in autism children. Propofol sedation for endoscopic procedures is safe and acceptable for children, especially those who express significant anxiety. Propofol-based sedation turned out to be the most effective dosage regimens, with effectiveness comparable to general anesthesia. The addition of certain dose ketamine to propofol may increase the effectiveness without creating more adverse events.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 46 is close to the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 67 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
eskatemine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Drug: Esketamine · Drug: Propofol
eskatemine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Drug: Esketamine · Drug: Propofol
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.
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.
propofol
Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.
Time frame: 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
The objective is to determine the effective bolus dose in 95% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.
Time frame: Procedure (This outcome is measured at the time of insertion of colonoscopy)
movement score during the procedure
(1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
Time frame: during the procudure
arterial blood pressure
arterial blood pressure was measured noninvasively at four time points:T0: before induction of sedation,T1: immediately after induction of sedation, T2: complete evaluation of the coln through colonoscopy, T3: at the end of colonic TET procedure。
Time frame: during the procudure
adverse event
(including hypoxia (SpO2 \<93% for \>10 s) or respiratory depression (apnea \>15 s), hypotension (MAP \< 20% from baseline) or bradycardia (HR \< 60 x/min and/or decrease in HR \> 20% from baseline) were recorded.
Time frame: during the procedure - 24 hours after procedure
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Nanjing Medical University