Patient state index changes following a bolus dose of dexmedetomidine in children with global developmental delay.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Dr Radhakrishnan M
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient state index
概览
简要总结
Global developmental delay (GDD) is a relatively common neurodevelopmental disorder. These children, when subjected to magnetic resonance imaging (MRI) studies, require sedation and analgesia to achieve immobility and obtain clear images. For children requiring sedation for MRI study, it is our practice to administer a bolus dose of dexmedetomidine over 10 minutes followed by a continuous infusion with additional doses of midazolam, propofol or ketamine as rescue drugs, to keep the child sedated. The changes in PSI during dexmedetomidine administration in children with GDD is not studied earlier. The need for rescue medications to complete the study might differ between children with and without GDD. In this study, the investigators plan to study the changes in PSI as a measure of sedation in children following a bolus dose of dexmedetomidine and compare it with children not having GDD.
This is a prospective study to evaluate patient state index changes following a bolus dose of dexmedetomidine in children with global developmental delay.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1-16 years posted for MRI (brain with infratentorial pathology, spine, GDD) under sedation
- •ASA physical status I-II.
排除标准
- •Children with pathology in the supratentorial intracranial compartment
- •ASA physical status III and above
- •Patients requiring sedatives other than Dexmedetomidine in the initial 10min bolus dose administration
- •Children with endotracheal tube in situ or requires intubation during the study.
结局指标
主要结局
Patient state index
时间窗: baseline,after 10min bolus dose of Dexmeditomidine
次要结局
- RSA with PSI value between GDD and non-GDD(every 5min)
- PSI and RSA at discharge between GDD and non-GDD(discharge)
- movement episodes and rescue drug(every 5min)
研究者
Dr Radhakrishnan M
National institute of Mental Health and Neurosciences