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

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: Dexmedetomidine

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.

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou Women and Children Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children undergoing MR scanning at Guangzhou Women and Children Medical Center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autism Spectrum Disorder; Patients with a diagnosis of autism spectrum disorder	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); Other Names: intranasal dexmedetomidine
Control; Patients with no developmental diagnoses	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); Other Names: intranasal dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: Ying-Jun She, MD., Guangzhou Women and Children Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): September 17, 2020
• Study Completion (Actual): September 18, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Autism Spectrum Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Intranasal dexmedetomidine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No