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临床试验/NCT06633315
NCT06633315已完成2 期

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

Maternal and Child Health Hospital of Hubei Province1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
The first success rate of nasal drip

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

The first success rate of nasal drip

时间窗: during the procedure

After the first dose of nasal drip administration, the examination was successfully completed and effective diagnostic images and reports were obtained.

次要结局

未报告次要终点

研究者

发起方
Maternal and Child Health Hospital of Hubei Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Na

Deputy chief physician

Maternal and Child Health Hospital of Hubei Province

研究点 (1)

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