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

Autism Spectrum Disorder Clinical Trial

Official title:

Intranasal Dexmedetomidine Combined With Oral Midazolam for Procedure Sedation in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597477
• Other study ID #: Intranasal dexmedetomidine
• Status: Completed
• Start date: July 16, 2018
• Est. completion date: September 18, 2020

Study information

• Verified date: February 2021
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 18, 2020
• Est. primary completion date: September 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexmedetomidine
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)

Locations

Country	Name	City	State
China	Guangzhou Women and Children Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; Does not respond to mild prodding or shaking; Responds only after mild prodding or shaking; Responds only after name is called loudly or repeatedly; Lethargic response to name spoken in normal tone; Appears asleep, but responds readily to name spoken in normal tone; Appears alert and awake, responds readily to name spoken in normal tone	up to 1 hours after MRI scanning
Secondary	sedation induction time	Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from midazolam and dexmedetomidine administration to the onset of satisfactory sedation	up to 45 min after drug administration
Secondary	Wake -up time	Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke	up to 4 hours after drug administration