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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorder | Patients with a diagnosis of autism spectrum disorder |
| |
| Control | Patients with no developmental diagnoses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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
| up to 1 hours after MRI scanning |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children undergoing MR scanning at Guangzhou Women and Children Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Ying-Jun She, MD. | Guangzhou Women and Children Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Women and Children Medical Center | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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 |