右美托咪定诱导慢性失眠障碍患者充分镇静的 95%有效剂量：一项偏倚硬币设计上下序贯分配试验。
The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder: a biased coin design up-and-down sequential allocation trial.
机构信息
Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, China.
出版信息
BMC Anesthesiol. 2024 Oct 11;24(1):368. doi: 10.1186/s12871-024-02759-4.
BACKGROUND
Chronic insomnia disorder is a common sleep disorder. Previous studies have reported increased demand for anesthetics in patients with chronic insomnia disorder. However, few studies have investigated the effective dose of dexmedetomidine for sedation in patients with chronic insomnia disorder. We aimed to determine the 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder.
METHODS
This is a biased coin design up-and-down sequential allocation trial in patients aged 18-65 years with chronic insomnia disorder (n = 60). The dose of dexmedetomidine for the subsequent patient was determined based on the response of the previous patient, with an interval of 0.1 µg/kg. Sedation was assessed using the bispectral index. The 95% effective dose was calculated using isotonic regression.
RESULTS
The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 (95% confidence interval, 1.70-1.94) µg/kg. Four patients (6.7%) experienced bradycardia and no other adverse events were observed during the study.
CONCLUSIONS
The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 µg/kg.
TRIALS REGISTRATION
Chinese Clinical Trial Registry (ChiCTR2200063212); first registered 01/09 /2022.
背景
慢性失眠障碍是一种常见的睡眠障碍。既往研究报道慢性失眠障碍患者对麻醉剂的需求增加。然而，很少有研究调查右美托咪定用于慢性失眠障碍患者镇静的有效剂量。我们旨在确定右美托咪定诱导慢性失眠障碍患者充分镇静的 95%有效剂量。
方法
这是一项在 18-65 岁慢性失眠障碍患者（n=60）中进行的偏倚硬币设计上下序贯分配试验。根据前一位患者的反应确定下一位患者的右美托咪定剂量，间隔为 0.1μg/kg。使用双谱指数评估镇静程度。使用等张回归计算 95%有效剂量。
结果
右美托咪定诱导慢性失眠障碍患者充分镇静的 95%有效剂量为 1.75（95%置信区间，1.70-1.94）μg/kg。4 名患者（6.7%）出现心动过缓，研究期间未观察到其他不良事件。
结论
右美托咪定诱导慢性失眠障碍患者充分镇静的 95%有效剂量为 1.75μg/kg。
试验注册
中国临床试验注册中心（ChiCTR2200063212）；首次注册日期 2022 年 1 月 9 日。
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