摘要译文(供参考)
在接受乳房手术的患者中,丙泊酚或瑞马唑仑(氟马西尼拮抗)全凭静脉麻醉的恢复情况比较:一项随机对照试验
【背景】
瑞马唑仑是一种短效苯二氮卓类药物,用于全身麻醉。比较丙泊酚与瑞马唑仑术后恢复的研究结果不一致。鉴于氟马西尼可逆转瑞马唑仑的镇静作用,我们假设它会加速瑞马唑仑全身麻醉的术后恢复。
【目标】
该试验的目的是比较接受微创乳房手术的患者从丙泊酚或瑞马唑仑(氟马西尼拮抗)全身麻醉中恢复的速度。
【设计】
随机、单中心、双盲对照试验。
【机构】
2022 年 8 月至 2022 年 12 月在韩国三级教学医院。
【病人】
即将接受全身麻醉以进行预定乳腺癌手术的成年患者(≥19 岁)。
【干预】
患者被随机分配到丙泊酚组或瑞马唑仑(氟马西尼拮抗)组。只有一名麻醉医师监测恢复过程。
【主要结局指标】
主要结局指标是在全身麻醉恢复期间睁开眼睛接受指挥的时间。
将声门上气道 (SGA) 拔除到出恢复室时间和恢复过程 Riker 镇静激动量表 (SAS) 评分(1 至 4)作为次要结局进行比较。
【结果】
瑞马唑仑组的平均睁眼时间明显短于丙泊酚组[127±51 vs. 314±140 s;平均差187 s(95%置信区间(CI),133-241 s; P < 0.001]。
瑞马唑仑组拔除SGA的时间也较短[169±51 vs. 366±149 s;平均差198 s(95%CI,140-255 s);P < 0.001]
出手术室的时间较短[243±55 vs. 449 ± 159 s;平均差 206 s(95% CI,145-267 s);P < 0.001]。
恢复期间的SAS评分差异也有统计学意义,评分均为4分的丙泊酚组1例,瑞马唑仑组25例(P < 0.001)。
【结论】
对于接受乳腺癌手术的患者来说,瑞马唑仑(氟马西尼拮抗)可能是一个有前途的选择,在全身麻醉苏醒期间,与丙泊酚相比,瑞马唑仑的恢复速度更快,SAS评分更好。
原文摘要
Comparison of recovery profiles between total intravenous anaesthesia with propofol or remimazolam reversed with flumazenil in patients undergoing breast surgery
A randomised controlled trial
BACKGROUND
Remimazolam, a short acting benzodiazepine, is being used for general anaesthesia. The results of studies comparing recovery after propofol with that of remimazolam are inconsistent. Given that flumazenil reverses the sedative effects of remimazolam, we hypothesised that it would speed up recovery from remimazolam general anaesthesia.
OBJECTIVES
The aim of this trial was to compare the speed of recovery from general anaesthesia between propofol and remimazolam reversed with flumazenil in patients undergoing minimally invasive breast surgery.
DESIGN
Randomised, single-centre, double-blind controlled trial.
SETTING
A tertiary teaching hospital in South Korea from August 2022 to December 2022.
PATIENTS
Adult patients (≥19 years of age) about to undergo general anaesthesia for scheduled breast cancer surgery.
INTERVENTIONS
Patients were randomly allocated to either the propofol or the remimazolam/flumazenil group. The emergence process was monitored by only one anaesthesiologist.
MAIN OUTCOME MEASURES
The primary outcome was the time to eye opening to command during recovery from the general anaesthesia. Time to removal of the supraglottic airway (SGA) time to discharge, and the Riker sedation agitation scale (SAS) score (1 to 4) during emergence were compared as secondary outcomes.
RESULTS
The remimazolam group had a significantly shorter mean time to eye opening than the propofol group [127 ± 51 vs. 314 ± 140 s; mean difference 187 s (95% confidence interval (CI), 133 to 241 s;P < 0.001]. The remimazolam group also had shorter times to SGA removal [169 ± 51 vs. 366 ± 149 s; mean difference 198 s (95% CI, 140 to 255 s); P < 0.001] and time to discharge from the operating room [243 ± 55 vs. 449 ± 159 s; mean difference 206 s (95% CI, 145 to 267 s); P < 0.001]. The SAS scores during emergence also differed significantly, with 1 patient in the propofol group and 25 in the remimazolam group attaining scores of 4 (P < 0.001).
CONCLUSION
Administration of remimazolam with flumazenil may be a promising option for patients undergoing breast cancer surgery, providing faster recovery and better SAS scores than propofol during emergence from general anaesthesia.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT05435911).
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