Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

Autism Spectrum Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05951465
• Other study ID #: esketamine 2023 N002
• Status: Completed
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: May 2023
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• 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.
• 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.
• Propofol
propofol

Locations

Country	Name	City	State
China	Sir Run Run Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	SIR RUN RUN hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Procedure (This outcome is measured at the time of insertion of colonoscopy)
Primary	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.	Procedure (This outcome is measured at the time of insertion of colonoscopy)
Secondary	movement score during the procedure	(1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)	during the procudure
Secondary	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?	during the procudure
Secondary	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.	during the procedure - 24 hours after procedure