Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- successful rescue sedation rate
研究概览
简要总结
The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning
排除标准
- •known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.
研究组 & 干预措施
chloral hydrate group
chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
干预措施: chloral hydrate Group (Drug)
low dose dexmedetomidine Group
Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.
干预措施: low dose dexmedetomidine group (Drug)
high dose dexmedetomidine group
Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.
干预措施: high dose dexmedetomidine group (Drug)
结局指标
主要结局
successful rescue sedation rate
时间窗: up to 1 hours after MRI scaning
Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1). successful sedation was defined as an MOAA/S of between 0 and 3
次要结局
- sedation induction time(up to 30 min after rescue drug administration)
- Wake -up time(up to 4 hours after rescue drug administration)
研究者
Wenhua Zhang
Bureau of Health of Guangzhou
Guangzhou Women and Children's Medical Center