Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging

NCT03597477 | Completed DMC

• 1 other identifier: Intranasal dexmedetomidine
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Autism spectrum disorders (ASD) is a neurodevelopmental disorder and is characterized by functional impairment in social communication, restricted interests, and repetitive behaviors.The children with ASD has been shown different drug responses from the normal population of children. The children with ASD maybe more prone to elevate anxiety and the difficult of sedation during MRI scanning.The purpose of this investigation was to compare the effectiveness of dexmedetomidine sedation in children with and without ASD undergoing MRI scanning.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• The 50% and 95% effective doses of intranasal dexmedetomidine

  Children were randomly allocated to receive sedation with 1 of 4 doses (1.0, 1.5, 2.0, and 2.5 ug/kg) of dexmedetomidine. Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).Successful sedation was defined as an MOAA/S of between 0 and 3. Probit analysis (linear regression plot of log concentration vs percentage response) was used to estimate the 50% and 95% effective concentration values of dexmedetomidine. MOAA/S scale: 0 Does not respond to a noxious stimulus 1. Does not respond to mild prodding or shaking 2. Responds only after mild prodding or shaking 3. Responds only after name is called loudly or repeatedly 4. Lethargic response to name spoken in normal tone 5. Appears asleep, but responds readily to name spoken in normal tone 6. Appears alert and awake, responds readily to name spoken in normal tone

  up to 1 hours after MRI scanning

Secondary Outcomes (2)

• sedation induction time

  up to 45 min after drug administration

• Wake -up time

  up to 4 hours after drug administration

Study Arms (2)

Autism Spectrum Disorder

Patients with a diagnosis of autism spectrum disorder

Drug: Dexmedetomidine

Control

Patients with no developmental diagnoses

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

participants were randomly allocated to receive sedation with oral midazolam(0.3 mg/kg) combined with 4 doses of intranasal dexmedetomidine(1.0, 1.5, 2.0, 2.5)

Also known as: intranasal dexmedetomidine

Autism Spectrum Disorder; Control

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing MR scanning at Guangzhou Women and Children Medical Center

You may qualify if:

• ASA physical status I or II,
• Patients aged 2 years through 12 years of age scheduled for procedure sedation during MRI scanning
• Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM V (autism group) or no history of neurodevelopmental concerns (control group). Child in control group is matched to an autism spectrum disorder participant according to age, gender, and ASA level.

You may not qualify if:

• Known allergy or hypersensitive reaction to dexmedetomidine
• Organ dysfunction, and significant developmental delays or behavior problems
• Cardiac arrhythmia
• Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ying-Jun She, MD.

  Guangzhou Women and Children Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Resesearch, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 24, 2018
• Study Start: July 16, 2018
• Primary Completion: September 17, 2020
• Study Completion: September 18, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

CN (1)