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Esketamine Combined With Dexmedetomidine Sedation in Head MRI Examination of Children With Autism Spectrum Disorder

Application of Ketamine Combined With Dexmedetomidine Sedation in Magnetic Resonance Imaging of Children With Autism and Autism Spectrum Disorder:a-Randomized Controlled Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06633315
Enrollment
300
Registered
2024-10-09
Start date
2022-12-01
Completion date
2024-09-01
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Dexmedetomidine, Esketamine, Sedation

Brief 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 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.

Interventions

OTHERlow dos dexmedetomidine

received dexmedetomidine 2.5 μ g/kg nasal drops

OTHERhigh dos dexmedetomidine

received dexmedetomidine 3 μ g/kg nasal drops

OTHERdexmedetomidine and esketamine

received dexmedetomidine 2 μ g/kg nasal drops plus ketamine 0.5 mg/kg nasal drops

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention 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

Eligibility

Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
No

Inclusion criteria

Clinical diagnosis of autism spectrum disorder Aged 2-6 years, ASA grade I or II

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
The first success rate of nasal dripduring the procedureAfter the first dose of nasal drip administration, the examination was successfully completed and effective diagnostic images and reports were obtained.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026