Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 主要终点
- Dose
研究概览
简要总结
This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. We will test its effectiveness in completing MRI scans in children that would otherwise be given a full general anesthetic.
详细描述
Purpose:
To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan in children.
Hypothesis:
We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age group.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1 or 2
- •Scheduled for elective MRI scan on the general anesthesia list
- •Child Life MRI simulation score of 6-10 (Figure 1)
- •Age 3 - 18
排除标准
- •Taking existing opioid, sedative, or cannabinoid medication
- •Severe learning disability defined as the inability to follow simple commands
- •Severe Cardiac disease
- •Chronic hypertension
- •Allergy to dexmedetomidine
- •Nasal anatomical abnormality
- •Known or anticipated difficult airway
研究组 & 干预措施
Intra-nasal dexmedetomidine
A single dose of dexmedetomidine, determined by a biased coin algorithm (min: 1 mcg/kg; max: 4 mcg/kg or 200mcg), will be delivered intranasally 45min before an MRI scan.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dose
时间窗: Immediately after completion of the MRI scan.
The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).
次要结局
- Uninterrupted scans(Immediately after completion of the MRI scan.)
- Respirator support(During MRI scan)
- Adverse events(During MRI scan)
- modified Yale Preoperative Anxiety Scale (mYPAS)(Immediately before administration of intranasal dexmedetomidine)
研究者
Mark Ansermino
Associate Professor
University of British Columbia