Clinical trial NCT03597477: Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging
Official title: Intranasal Dexmedetomidine Combined With Oral Midazolam for Procedure Sedation in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Dexmedetomidine
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 136
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing MR scanning at Guangzhou Women and Children Medical Center

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.

Detailed description: The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications for procedural sedation in this population. It's advisable to be used as a first line medication with alpha-2 agonists for procedure sedation. The primary goal of this study was to compare the effectiveness of dexmedetomidine sedation, also determine the 50% and 95% effective doses in children with and without ASD undergoing MRI scanning.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The 50% and 95% effective doses of intranasal dexmedetomidine
timeFrame: up to 1 hours after MRI scanning
Secondary outcomes:
measure: sedation induction time
timeFrame: up to 45 min after drug administration
measure: Wake -up time
timeFrame: up to 4 hours after drug administration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children Medical Center
name: Ying-Jun She, MD.
role: PRINCIPAL_INVESTIGATOR
References: