Intranasal Dexmedetomidine Combined With Oral Midazolam for Procedure Sedation in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The 50% and 95% effective doses of intranasal dexmedetomidine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Autism Spectrum Disorder
Patients with a diagnosis of autism spectrum disorder
干预措施: Dexmedetomidine (Drug)
Control
Patients with no developmental diagnoses
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The 50% and 95% effective doses of intranasal dexmedetomidine
时间窗: 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
次要结局
- sedation induction time(up to 45 min after drug administration)
- Wake -up time(up to 4 hours after drug administration)
研究者
Ying Jun She, MD
Director, Clinical Resesearch, Department of Anesthesiology and Perioperative Medicine
Guangzhou Women and Children's Medical Center