Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633315
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Esketamine Combined With Dexmedetomidine Sedation in Head MRI Examination of Children With Autism Spectrum Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application of Ketamine Combined With Dexmedetomidine Sedation in Magnetic Resonance Imaging of Children With Autism and Autism Spectrum Disordera-Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder Methodsaged 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 groupn100The high-dose group of dexmedetomidine DEXH groupn100 and the group of esketamine combined with dexmedetomidine DEXE groupn100 The DEXL group received 25 μ gkg of dexmedetomidine nasal drops the DEXH group received 3 μ gkg of dexmedetomidine nasal drops and the DEXE group received 2 μ gkg of dexmedetomidine nasal drops plus 05 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None