Skip to main content
OpenTrials
Completed

NCT Number: NCT05951465

Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Hospital

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esketamine

Drug

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.

Propofol

Drug

propofol

Primary outcomes

  1. Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1

    Time frame: Procedure (This outcome is measured at the time of insertion of colonoscopy)

    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.

  2. Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2

    Time frame: Procedure (This outcome is measured at the time of insertion of colonoscopy)

    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.

Secondary outcomes

  1. movement score during the procedure

    Time frame: during the procudure

    (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)

  2. arterial blood pressure

    Time frame: during the procudure

    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。

  3. adverse event

    Time frame: during the procedure - 24 hours after procedure

    (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.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Nanjing Medical University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.