Department of Anesthesiology, School of Medicine, Kitasato, Kanagawa, Japan.
Department of Pharmacy, Kitasato University Hospital, Kitasato, Kanagawa, Japan.
Acta Anaesthesiol Scand. 2022 Aug;66(7):818-822. doi: 10.1111/aas.14077. Epub 2022 May 13.
Preanesthetic medication is important to eliminate surgical anxiety in pediatric patients and facilitate their smooth transfer to the operating room. Midazolam is the most commonly used preanesthetic medication. However, it has been reported that the sedative effect varies from patient to patient. In this study, the pharmacokinetics of midazolam were examined, and the aim was to assess the factors affecting the quality of sedation.
The participants were children ranging in age from 6 months to 8 years scheduled for surgery. Midazolam 0.5 mg/kg was administered orally 30 min before entering the operating room, and the sedation level was evaluated at the time of mask application. Blood was collected after slow induction, and the serum concentration of midazolam was measured using high-performance liquid chromatography.
A total of 98 patients were registered. There was no difference in serum concentrations between the effective sedation group and the ineffective sedation group (48.0 vs. 49.1 ng/mL), regardless of the effect of midazolam. Percentages of ineffective sedation by age (0 to 7 years) were 66.6%, 60%, 33.3%, 11.1%, 0%, 0%, 12.5%, and 0%, respectively. On multivariate logistic regression analysis, siblings (OR = 3.9, CI: 1.1-14.0, p = .03) and age (OR = 3.2, CI:1.2-8.5, p = .02) were related to an insufficient sedative effect.
The serum concentration of oral midazolam reached effective levels even in patients in whom the sedative effect was inadequate. It is important to manage the perioperative period with appropriate concurrent premedication taking into account patient age and social background characteristics.
Clinical trial registry: UMIN R000052504.
术前用药对于消除小儿患者的手术焦虑，促进其平稳转入手术室至关重要。咪达唑仑是最常用的术前用药。但有报道称，其镇静效果因人而异。本研究旨在考察咪达唑仑的药代动力学，并评估影响镇静质量的因素。
本研究纳入了年龄在 6 个月至 8 岁拟行手术的患儿。患儿于进入手术室前 30 分钟口服咪达唑仑 0.5mg/kg，在给予面罩时评估镇静水平。缓慢诱导后采集血样，采用高效液相色谱法测定咪达唑仑的血清浓度。
共登记了 98 例患者。有效镇静组和无效镇静组的血清浓度无差异（48.0 vs. 49.1ng/mL），与咪达唑仑的效果无关。按年龄（0 至 7 岁）分组，无效镇静的比例分别为 66.6%、60%、33.3%、11.1%、0%、0%、12.5%和 0%。多变量 logistic 回归分析显示，兄弟姐妹（OR=3.9，CI：1.1-14.0，p=0.03）和年龄（OR=3.2，CI：1.2-8.5，p=0.02）与镇静效果不足相关。
即使在镇静效果不足的患者中，口服咪达唑仑的血清浓度也达到了有效水平。考虑到患者年龄和社会背景特点，管理围手术期时，适当的同时进行术前用药非常重要。
UMIN R000052504。
