Obata Yukako, Adachi Yushi U, Suzuki Katsumi, Itagaki Taiga, Kato Hiromi, Satomoto Maiko, Nakajima Yoshiki
Department of Intensive Care Unit, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 4313192, Japan.
Department of Intensive Care Medicine, Tokyo Medical and Dental University Medical Hospital, Tokyo, Japan.
Anesthesiol Res Pract. 2016;2016:9178523. doi: 10.1155/2016/9178523. Epub 2016 Jan 21.
Background. Propofol is a popular intravenous anesthetic and varieties of formulations were produced from different laboratories. The present study compared efficacy of propofol of different laboratories and different concentrations (1 and 2%) during induction of anesthesia. Methods. Seventy-five scheduled surgical patients were randomly allocated into three groups. The patients of group D1 received AstraZeneca Diprivan 1% (Osaka, Japan) at a rate of 40 mg kg(-1) h(-1). Group M1 was given 1% Maruishi (Maruishi Pharmaceutical, Osaka, Japan) and group M2 was given 2% formulation at the same rate of propofol. Achieving hypnosis was defined as failure to open their eyes in response to a verbal command and the venous blood sample was withdrawn. Results. The hypnotic doses of M2 were significantly larger (D1: 91.4 ± 30.9, M1: 90.7 ± 26.7, and M2: 118.4 ± 40.2 mg, resp. (mean ± SD). p < 0.005). Age and gender were selected as statistically significant covariates using general linear model-ANOVA. The blood concentration showed no significant difference among the groups (3.73 ± 2.34, 4.10 ± 3.04, and 4.70 ± 2.12 μg mL(-1), resp.). Conclusion. The required dose of propofol was different among the formulations; however, the serum concentration showed no significant difference. This trial is registered with UMIN Clinical Trial Registry: UMIN000019925.
背景。丙泊酚是一种常用的静脉麻醉药,不同实验室生产了多种制剂。本研究比较了不同实验室和不同浓度(1%和2%)的丙泊酚在麻醉诱导期间的疗效。方法。75例择期手术患者被随机分为三组。D1组患者以40mg·kg⁻¹·h⁻¹的速率接受阿斯利康得普利麻1%(日本大阪)。M1组给予1%丸石(丸石制药,日本大阪),M2组给予相同丙泊酚速率的2%制剂。达到催眠状态定义为对言语指令无睁眼反应,并采集静脉血样。结果。M2组的催眠剂量显著更大(分别为D1组:91.4±30.9,M1组:90.7±26.7,M2组:118.4±40.2mg,(均值±标准差)。p<0.005)。使用一般线性模型方差分析将年龄和性别选为具有统计学意义的协变量。各组间血药浓度无显著差异(分别为3.73±2.34、4.10±3.04和4.70±2.12μg·mL⁻¹)。结论。不同制剂的丙泊酚所需剂量不同;然而,血清浓度无显著差异。本试验已在UMIN临床试验注册中心注册:UMIN000019925。