经胸超声心动图检查中心脏手术后和正常儿童鼻腔内右美托咪定镇静的有效中位剂量：上下序贯分配试验。
Median effective dose of intranasal dexmedetomidine sedation for transthoracic echocardiography examination in postcardiac surgery and normal children: An up-and-down sequential allocation trial.
机构信息
From the Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders (YL, QY, MS, SL, JZ, YL, CL, FY, ST), China International Science and Technology Cooperation base of Child development and Critical Disorders (YL, QY, MS, JZ) and Chongqing Key Laboratory of Pediatrics, Chongqing, China (YL, QY, MS, JZ).
出版信息
Eur J Anaesthesiol. 2018 Jan;35(1):43-48. doi: 10.1097/EJA.0000000000000724.
BACKGROUND
Dexmedetomidine (DEX) has been used for sedation in young infants and children undergoing transthoracic echocardiography (TTE). The median effective dose of intranasal DEX has not been described for postcardiac surgery children. Postcardiac surgery children could require more DEX to achieve satisfactory sedation for TTE examination than children suspected of congenital heart disease.
OBJECTIVES
To study whether postcardiac surgery children need a larger dose of DEX for TTE than normal children.
DESIGN
A double-blind sequential allocation trial with doses determined by the Dixon and Massey up-and-down method.
SETTING
A tertiary care teaching hospital from 25 October to 30 November 2016.
PATIENTS
Children under the age of 3 years requiring intranasal DEX for TTE.
INTERVENTIONS
Children were allocated to a postcardiac surgery group (n = 20) or a normal group (n = 19). The first patient in both groups received intranasal DEX (2 μg kg): using the up-and-down method of Dixon and Massey, the next dose was dependent on the previous patient's response.
MAIN OUTCOME MEASURES
Median effective dose was estimated from the up-and-down method of Dixon and Massey and probit regression. A second objective was to study haemodynamic stability and adverse events with these doses.
RESULTS
The median effective dose (95% confidence interval) of intranasal DEX was higher in postcardiac surgery children than in normal children, 3.3 (2.72 to 3.78) μg kg versus 1.8 (1.71 to 2.04) (μg kg), respectively (P < 0.05). There were no significant differences in time to sedation, time to wake-up or TTE examination time between the two groups for successful sedation. Additionally, there were no significant adverse events.
CONCLUSION
The median effective dose of intranasal DEX for TTE sedation in postcardiac surgery children was higher than in normal children.
TRIAL REGISTRATION
chictr.org.cn identifier: ChiCTR-OOC-16009846.
背景
右美托咪定（DEX）已被用于经胸超声心动图（TTE）检查的婴幼儿镇静。但尚未描述心脏手术后儿童经鼻给予 DEX 的中效剂量。心脏手术后的儿童在 TTE 检查时，可能需要更多的 DEX 来达到满意的镇静效果，而不是怀疑患有先天性心脏病的儿童。
目的
研究心脏手术后的儿童在 TTE 检查时是否需要比正常儿童更大剂量的 DEX。
设计
采用 Dixon 和 Massey 上下法确定剂量的双盲序贯分配试验。
地点
2016 年 10 月 25 日至 11 月 30 日，三级保健教学医院。
患者
需要 TTE 经鼻给予 DEX 的 3 岁以下儿童。
干预措施
将患儿分为心脏手术后组（n = 20）或正常组（n = 19）。两组中的第一个患儿均接受 2 μg/kg 的经鼻 DEX：采用 Dixon 和 Massey 的上下法，下一个剂量取决于前一个患儿的反应。
主要观察指标
通过 Dixon 和 Massey 的上下法和概率回归来估计中效剂量。第二个目标是研究这些剂量的血流动力学稳定性和不良反应。
结果
心脏手术后儿童的经鼻 DEX 中效剂量（95%置信区间）高于正常儿童，分别为 3.3（2.72 至 3.78）μg/kg 与 1.8（1.71 至 2.04）μg/kg（P < 0.05）。在成功镇静的情况下，两组之间镇静时间、清醒时间或 TTE 检查时间均无显著差异。此外，两组均无明显不良反应。
结论
心脏手术后儿童 TTE 镇静的经鼻 DEX 中效剂量高于正常儿童。
临床试验注册
chictr.org.cn 标识符：ChiCTR-OOC-16009846。
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