Yokose Masashi, Takaki Ryuki, Mihara Takahiro, Saigusa Yusuke, Yamamoto Natsuhiro, Masui Kenichi, Goto Takahisa
Department of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Department of Health Data Science, Yokohama City University Graduate School of Data Science, Yokohama, Japan.
PLoS One. 2022 Sep 30;17(9):e0275451. doi: 10.1371/journal.pone.0275451. eCollection 2022.
In geriatric patients, hypotension is often reported after general anesthesia induction using propofol. Remimazolam is a novel short-acting sedative. However, the incidence of hypotension after general anesthesia induction using remimazolam in geriatric patients remains unclear. This study aims to compare the incidence of hypotension associated with remimazolam and propofol in patients aged ≥80 years.
This single-center, double-blind, randomized, two-arm parallel group, standard treatment-controlled, interventional clinical trial will include 90 patients aged ≥80 years undergoing elective surgery under general anesthesia who will be randomized to receive remimazolam or propofol for induction. The primary outcome is the incidence of hypotension after general anesthesia induction, occurring between the start of drug administration and 3 min after intubation. We define hypotension as mean blood pressure <65 mmHg. The primary outcome will be analyzed using the full analysis set. The incidence of hypotension in the two groups will be compared using the Mantel-Haenszel χ2 test. Subgroup analysis of the primary outcome will be performed based on the Charlson comorbidity index, clinical frailty scale, hypertension in the ward, and age. Secondary outcomes will be analyzed using the Fisher's exact test, Student's t test, and Mann-Whitney U test, as appropriate. Logistic regression analysis will be performed to explore the factors associated with the incidence of hypotension after anesthesia induction.
Our trial will determine the efficacy of remimazolam in preventing hypotension and provide evidence on the usefulness of remimazolam for ensuring hemodynamic stability during general anesthesia induction in geriatric patients.
The study has been registered with UMIN Clinical Trials Registry (UMIN000042587), on June 30, 2021.
在老年患者中，使用丙泊酚进行全身麻醉诱导后常出现低血压。瑞马唑仑是一种新型短效镇静剂。然而，老年患者使用瑞马唑仑进行全身麻醉诱导后低血压的发生率尚不清楚。本研究旨在比较≥80岁患者中瑞马唑仑和丙泊酚相关低血压的发生率。
本单中心、双盲、随机、双臂平行组、标准治疗对照的干预性临床试验将纳入90例≥80岁接受全身麻醉下择期手术的患者，他们将被随机分配接受瑞马唑仑或丙泊酚进行诱导。主要结局是全身麻醉诱导后低血压的发生率，发生在给药开始至插管后3分钟之间。我们将低血压定义为平均血压<65 mmHg。主要结局将使用全分析集进行分析。两组低血压的发生率将使用Mantel-Haenszel χ2检验进行比较。主要结局的亚组分析将根据Charlson合并症指数、临床衰弱量表、病房高血压情况和年龄进行。次要结局将根据情况使用Fisher精确检验、Student t检验和Mann-Whitney U检验进行分析。将进行逻辑回归分析以探讨与麻醉诱导后低血压发生率相关的因素。
我们的试验将确定瑞马唑仑预防低血压的疗效，并为瑞马唑仑在老年患者全身麻醉诱导期间确保血流动力学稳定性的有用性提供证据。
该研究已于2021年6月30日在UMIN临床试验注册中心（UMIN000042587）注册。
