Autism Spectrum DisorderNCT03597477
Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging
An observational study of Autism Spectrum Disorder, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Pill or oral medicine
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2018to 18 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children undergoing MR scanning at Guangzhou Women and Children Medical Center
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Dexmedetomidine
- Keywords
- Autism Spectrum Disorder, Dexmedetomidine
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called intranasal 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)
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Patients with a diagnosis of autism spectrum disorder Receives: Drug: Dexmedetomidine | |
| Control | Patients with no developmental diagnoses Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 hours after MRI scanning
Secondary outcomes (2)
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
Measured: 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
Measured: up to 4 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start16 Jul 2018
- Primary completion17 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jun She, MD, Guangzhou Women and Children's Medical Center
- Investigators
- Ying-Jun She, MD., Principal investigator, Guangzhou Women and Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597477
- Sponsor's protocol ID
- Intranasal dexmedetomidine
- Status last verified
- Feb 2021
- First submitted
- 10 Jul 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Combined With Oral Midazolam for Procedure Sedation in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03597477
- Acronym / sponsor ID
- Intranasal dexmedetomidine
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Dexmedetomidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | Drug: DexmedetomidinePatients with a diagnosis of autism spectrum disorder |
| Control | – | Drug: DexmedetomidinePatients with no developmental diagnoses |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children undergoing MR scanning at Guangzhou Women and Children Medical Center
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: intranasal dexmedetomidineparticipants 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) | Drug | Autism Spectrum Disorder, Control |
Primary outcome
The 50% and 95% effective doses of intranasal dexmedetomidine
Time frame: up to 1 hours after MRI scanning
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
2 secondary outcomes
sedation induction time
Time frame: up to 45 min after drug administration
Wake -up time
Time frame: up to 4 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Jun She, MD. principal investigator
Guangzhou Women and Children Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 50% and 95% effective doses of intranasal dexmedetomidine (time frame: up to 1 hours after MRI scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.