Clinical trial NCT05951465: Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy
Official title: Determination of the Median Effective Dose of Propofol in Combination With Different Doses of Esketamine During Colonoscopy for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: colonoscopy
anaesthesia
autism spectrum disorder
propofol
esketamine
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
First posted: 2023-07-19
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1
timeFrame: Procedure (This outcome is measured at the time of insertion of colonoscopy)
measure: Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2
timeFrame: Procedure (This outcome is measured at the time of insertion of colonoscopy)
Secondary outcomes:
measure: movement score during the procedure
timeFrame: during the procudure
measure: arterial blood pressure
timeFrame: during the procudure
measure: adverse event
timeFrame: during the procedure - 24 hours after procedure
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Sir Run Run Hospital
state: Jiangsu
Study officials:
References: