Suzuki Mariko (Mariko Iimura), Koshika Kyotaro, Ichinohe Tatsuya
Department of Dental Anesthesiology, Tokyo Dental College, Tokyo, Japan.
J Dent Anesth Pain Med. 2025 Feb;25(1):55-65. doi: 10.17245/jdapm.2025.25.1.55. Epub 2025 Jan 22.
Prompt awakening and sufficient recovery of psychomotor and equilibrium functions are important for day surgery. Flumazenil accelerates recovery of consciousness after remimazolam anesthesia, but its effects on psychomotor and equilibrium functions are not well known. The purpose of this study was to determine whether flumazenil improves time to recovery, psychomotor, and equilibrium functions in subjects undergoing remimazolam anesthesia.
The design was a single-center, double-blind, randomized, controlled trial. Inclusion criteria were patients aged 18-64 years scheduled for oral surgery under remimazolam anesthesia, with American Society of Anesthesiologists physical status I or II. The predictor variable was the use of a reversal agent (flumazenil group) versus placebo (non-flumazenil group). The primary outcome variable was recovery from sedation measured using the Modified Observer's Alertness/Sedation (MOAA/S) scale for wakefulness. Secondary outcome variables were psychomotor function measured using the Trieger Dot Test (number of dots missed [NDM], maximum distance of dots missed [MDDM]), and the digit symbol substitution test (DSST), as well as equilibrium function measured using the timed up and go test (TUG), and gravimetric area and speed. Statistical analyses were performed using the Mann-Whitney U test, χ test, Student's t-test, two-way ANOVA, and Bonferroni correction. P-values < 0.05 were considered significant.
Sixty-eight subjects were included (male: 33, female: 35). The mean time from extubation to an MOAA/S score of 5 (minutes) was 6.5 (1.5-10.5) in the flumazenil group and 13.5 (6.8-19.3) in the non-flumazenil group (P = 0.01). There was no significant difference in the recovery of psychomotor and balance functions between the two groups. However, the following measurements were significantly increased compared to baseline: NDM (P < 0.001) and DSST (P < 0.001) at 30 minutes, MDDM (P < 0.001), TUG (P < 0.001), and gravimetric speed (P < 0.001) at 60 minutes, and gravimetric area (P = 0.03) at 90 minutes.
Administration of flumazenil after remimazolam anesthesia resulted in faster recovery of consciousness, but it did not affect the recovery of psychomotor and equilibrium functions. The time until patients were safe to return home was 120 minutes. Flumazenil did not improve the time until it was safe for patients to return home.
快速苏醒以及精神运动和平衡功能的充分恢复对于日间手术很重要。氟马西尼可加速瑞马唑仑麻醉后意识的恢复，但其对精神运动和平衡功能的影响尚不清楚。本研究的目的是确定氟马西尼是否能改善接受瑞马唑仑麻醉患者的恢复时间、精神运动和平衡功能。
本研究为单中心、双盲、随机对照试验。纳入标准为年龄在18 - 64岁、计划在瑞马唑仑麻醉下行口腔手术、美国麻醉医师协会身体状况分级为I或II级的患者。预测变量为使用逆转剂（氟马西尼组）与安慰剂（非氟马西尼组）。主要结局变量是使用改良的观察者警觉/镇静（MOAA/S）量表测量的苏醒情况。次要结局变量包括使用特里格点试验（漏点数量[NDM]、漏点最大距离[MDDM]）和数字符号替换试验（DSST）测量的精神运动功能，以及使用定时起立行走试验（TUG）、重量面积和速度测量的平衡功能。采用曼 - 惠特尼U检验、χ检验、学生t检验、双向方差分析和邦费罗尼校正进行统计分析。P值<0.05被认为具有统计学意义。
共纳入68名受试者（男性33名，女性35名）。氟马西尼组从拔管到MOAA/S评分为5的平均时间（分钟）为6.5（1.5 - 10.5），非氟马西尼组为13.5（6.8 - 19.3）（P = 0.01）。两组在精神运动和平衡功能恢复方面无显著差异。然而，与基线相比，以下测量值显著增加：30分钟时的NDM（P < 0.001）和DSST（P < 0.001），60分钟时的MDDM（P < 0.001）、TUG（P < 0.001）和重量速度（P < 0.001），以及90分钟时的重量面积（P = 0.03）。
瑞马唑仑麻醉后给予氟马西尼可使意识恢复更快，但不影响精神运动和平衡功能的恢复。患者安全回家的时间为120分钟。氟马西尼并未缩短患者安全回家所需的时间。
