Autism Spectrum DisorderPhase 2NCT06633315
Esketamine Combined With Dexmedetomidine Sedation in Head MRI Examination of Children With Autism Spectrum Disorder
A Phase 2 study testing low dos dexmedetomidine, high dos dexmedetomidine and dexmedetomidine and esketamine in people with Autism Spectrum Disorder and Dexmedetomidine, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
Objective: To investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder, Methods:aged 2-6 years,, ASA grade I or II. The children were randomly divided into three groups using a random number table method: a low-dose dexmedetomidine group (DEXL group,n=100）The… Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Autism Spectrum Disorder, Dexmedetomidine, Esketamine
- What is being tested?
- low dos dexmedetomidine, high dos dexmedetomidine and dexmedetomidine and esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Sep 2024
- Phase
- Phase 2
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of autism spectrum disorder Aged 2-6 years, ASA grade I or II
Who cannot join
- Upper respiratory tract infections, Severe respiratory system related diseases Congenital heart disease Liver and kidney dysfunction. Contraindications for ketamine and dexmedetomidine, Expected difficult airways. Anesthetic or sedative drugs used in the last week.
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Hubei Province,
Wuhan, Hubei, 43000
About this study
Official title: Application of Ketamine Combined With Dexmedetomidine Sedation in Magnetic Resonance Imaging of Children With Autism and Autism Spectrum Disorder:a-Randomized Controlled Trial
Objective: To investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder, Methods:aged 2-6 years,, ASA grade I or II. The children were randomly divided into three groups using a random number table method: a low-dose dexmedetomidine group (DEXL group,n=100）The high-dose group of dexmedetomidine (DEXH group,n=100) and the group of esketamine combined with dexmedetomidine (DEXE group,n=100). The DEXL group received 2.5 μ g/kg of dexmedetomidine nasal drops, the DEXH group received 3 μ g/kg of dexmedetomidine nasal drops, and the DEXE group received 2 μ g/kg of dexmedetomidine nasal drops plus 0.5 mg/kg of ketamine nasal drops. Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3).
Read the detailed description
Autism Spectrum Disorder (ASD), also known as Autism Spectrum Disorder (ASD), is a condition in which approximately 60% to 70% of autistic children have intellectual disabilities that significantly affect their ability to take care of themselves and bring immense pressure to society and families. Autistic children often have neurological disorders, and therefore require head magnetic resonance imaging (MRI) examinations. MRI examinations can detect abnormal changes in brain structure and function, providing more objective evidence for early diagnosis and valuable treatment time for autistic patients. However, MRI examinations require children to maintain a calm and quiet state, minimizing physical activity as much as possible. Due to the specific interests and behaviors of autistic children, as well as their refusal to accept environmental changes, completing MRI examinations often requires sedation or anesthesia. The main drugs currently used for sedation in pediatric outpatient examinations include dexmedetomidine, midazolam, ketamine, etc. This study aims to select children with ASD who are scheduled to undergo head MRI in outpatient settings, and explore the safety and efficacy of intranasal administration of ketamine combined with dexmedetomidine for sedation, providing reference methods and evidence for sedation in children with autism spectrum disorder.
- Conditions
- Autism Spectrum Disorder, Dexmedetomidine, Esketamine, Sedation
- Being tested
- low dos dexmedetomidine, high dos dexmedetomidine, dexmedetomidine and esketamine
- 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.
low dos dexmedetomidineOther
received dexmedetomidine 2.5 μ g/kg nasal drops
high dos dexmedetomidineOther
received dexmedetomidine 3 μ g/kg nasal drops
dexmedetomidine and esketamineOther
received dexmedetomidine 2 μ g/kg nasal drops plus ketamine 0.5 mg/kg nasal drops
| Study group | Role | What they receive |
|---|---|---|
| High dose dexmedetomidine | Experimental | received high dose dexmedetomidine,received dexmedetomidine 3 μ g/kg nasal drops,Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients. Receives: Other: high dos dexmedetomidine |
| Dexmedetomidine and esketamine | Experimental | received dexmedetomidine plus esketamine ,received dexmedetomidine 2 μ g/kg nasal drops plus esketamine 0.5 mg/kg nasal drops.Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients. Receives: Other: dexmedetomidine and esketamine |
| Low dos dexmedetomidine | Experimental | received dexmedetomidine 2.5 μ g/kg nasal drops, Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients. Receives: Other: low dos dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first success rate of nasal drip
After the first dose of nasal drip administration, the examination was successfully completed and effective diagnostic images and reports were obtained.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Dec 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The children were randomly divided into three groups using a random number table method: The low-dose dexmedetomidine group ( DL group,n = 30) ， Group DL received dexmedetomidine 2.5 μ g/kg nasal drops, The high-dose group of dexmedetomidine (DH group),received dexmedetomidine 3 μ g/kg nasal drops The combination group (DE group, n=30). received dexmedetomidine 2 μ g/kg nasal drops plus esketamine 0.5 mg/kg nasal drops. Record the Modified Vigilance/Sedation (MOAA/S) Scale score, Mask Acceptance Scale (MAS) score, one-time medication success rate, and number of salvage medication cases 30 minutes after nasal drip. Record the vital signs of four groups of patients during the examination process, including their basic
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Linli Yue, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633315
- Sponsor's protocol ID
- MCHH_05
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ketamine Combined With Dexmedetomidine Sedation in Magnetic Resonance Imaging of Children With Autism and Autism Spectrum Disorder:a-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06633315
- Acronym / sponsor ID
- MCHH_05
- Conditions
- Autism Spectrum Disorder, Dexmedetomidine, Esketamine, Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 Oct 2024 (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.
Objective: To investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder, Methods:aged 2-6 years,, ASA grade I or II. The children were randomly divided into three groups using a random number table method: a low-dose dexmedetomidine group (DEXL group,n=100）The high-dose group of dexmedetomidine (DEXH group,n=100) and the group of esketamine combined with dexmedetomidine (DEXE group,n=100). The DEXL group received 2.5 μ g/kg of dexmedetomidine nasal drops, the DEXH group received 3 μ g/kg of dexmedetomidine nasal drops, and the DEXE group received 2 μ g/kg of dexmedetomidine nasal drops plus 0.5 mg/kg of ketamine nasal drops. Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3).
Detailed description
Autism Spectrum Disorder (ASD), also known as Autism Spectrum Disorder (ASD), is a condition in which approximately 60% to 70% of autistic children have intellectual disabilities that significantly affect their ability to take care of themselves and bring immense pressure to society and families. Autistic children often have neurological disorders, and therefore require head magnetic resonance imaging (MRI) examinations. MRI examinations can detect abnormal changes in brain structure and function, providing more objective evidence for early diagnosis and valuable treatment time for autistic patients. However, MRI examinations require children to maintain a calm and quiet state, minimizing physical activity as much as possible. Due to the specific interests and behaviors of autistic children, as well as their refusal to accept environmental changes, completing MRI examinations often requires sedation or anesthesia. The main drugs currently used for sedation in pediatric outpatient examinations include dexmedetomidine, midazolam, ketamine, etc. This study aims to select children with ASD who are scheduled to undergo head MRI in outpatient settings, and explore the safety and efficacy of intranasal administration of ketamine combined with dexmedetomidine for sedation, providing reference methods and evidence for sedation in children with autism spectrum disorder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The children were randomly divided into three groups using a random number table method: The low-dose dexmedetomidine group ( DL group,n = 30) ， Group DL received dexmedetomidine 2.5 μ g/kg nasal drops, The high-dose group of dexmedetomidine (DH group),received dexmedetomidine 3 μ g/kg nasal drops The combination group (DE group, n=30). received dexmedetomidine 2 μ g/kg nasal drops plus esketamine 0.5 mg/kg nasal drops. Record the Modified Vigilance/Sedation (MOAA/S) Scale score, Mask Acceptance Scale (MAS) score, one-time medication success rate, and number of salvage medication cases 30 minutes after nasal drip. Record the vital signs of four groups of patients during the examination process, including their basic
| Arm | Type | Receives |
|---|---|---|
| High dose dexmedetomidine | Experimental | Other: high dos dexmedetomidinereceived high dose dexmedetomidine,received dexmedetomidine 3 μ g/kg nasal drops,Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients. |
| Dexmedetomidine and esketamine | Experimental | Other: dexmedetomidine and esketaminereceived dexmedetomidine plus esketamine ,received dexmedetomidine 2 μ g/kg nasal drops plus esketamine 0.5 mg/kg nasal drops.Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients. |
| Low dos dexmedetomidine | Experimental | Other: low dos dexmedetomidinereceived dexmedetomidine 2.5 μ g/kg nasal drops, Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of autism spectrum disorder Aged 2-6 years, ASA grade I or II
Key exclusion criteria (1 listed)
- Upper respiratory tract infections, Severe respiratory system related diseases Congenital heart disease Liver and kidney dysfunction. Contraindications for ketamine and dexmedetomidine, Expected difficult airways. Anesthetic or sedative drugs used in the last week.
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 |
|---|---|---|
| low dos dexmedetomidinereceived dexmedetomidine 2.5 μ g/kg nasal drops | Other | Low dos dexmedetomidine |
| high dos dexmedetomidinereceived dexmedetomidine 3 μ g/kg nasal drops | Other | High dose dexmedetomidine |
| dexmedetomidine and esketaminereceived dexmedetomidine 2 μ g/kg nasal drops plus ketamine 0.5 mg/kg nasal drops | Other | Dexmedetomidine and esketamine |
Primary outcome
The first success rate of nasal drip
Time frame: during the procedure
After the first dose of nasal drip administration, the examination was successfully completed and effective diagnostic images and reports were obtained.
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 9 Oct 2024.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Linli Yue, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low dos dexmedetomidine, high dos dexmedetomidine and dexmedetomidine and esketamine in people with Autism Spectrum Disorder and Dexmedetomidine, run by Maternal and Child Health Hospital of Hubei Province 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 1 inclusion and 1 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 9 Oct 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 first success rate of nasal drip (time frame: during the procedure). 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 9 Oct 2024.