基于瑞马唑仑和丙泊酚的全凭静脉麻醉对术后恢复质量影响的比较:一项随机非劣效性试验

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基于瑞马唑仑和丙泊酚的全凭静脉麻醉对术后恢复质量影响的比较:一项随机非劣效性试验

贵州医科大学    麻醉与心脏电生理课题组

翻译：潘志军  编辑：潘志军  审校：曹莹

背景：通过QoR-15评分比较瑞马唑仑和丙泊酚全凭静脉麻醉的恢复质量（QoR）。

实验设计：一项前瞻性、双盲、随机对照、非劣效性试验。

范围设置：手术室，麻醉后监测治疗室(PACU)和病房。

受试者：共纳入140名20-65岁计划行开放性甲状腺切除术的女性患者，并随机分配到瑞马唑仑组和丙泊酚组。

干预措施：瑞马唑仑组持续输注瑞马唑仑和效应室靶控输注瑞芬太尼。丙泊酚组则效应室靶控输注丙泊酚和瑞芬太尼。

测量方法：主要结局指标为术后第1天(POD1)的QoR-15评分。两组之间的平均差异在−8的非劣效差范围内进行比较。次要结局指标包括POD2的QoR-15评分、血流动力学数据、意识消失和意识恢复的时间、PACU入院时的镇静评分、疼痛以及PACU和病房的术后恶心和呕吐情况。使用线性混合模型分析血流动力学数据和QoR-15中的组间相互作用效应。

主要 结果：瑞马唑仑组POD1的QoR-15总评分不低于丙泊酚组(均数[SD] 111.2 [18.8] vs. 109.1 [18.9]；平均差值[95% CI] 2.1[−4.2,8.5]；非劣效性P = 0.002)。POD2的QoR-15评分在两组之间具有可比性，并且没有观察到组间的相互作用。在麻醉结束、拔管后和到达PACU时，瑞马唑仑组的平均动脉压显著升高。瑞马唑仑组在入PACU时镇静效果较好。与丙泊酚组相比，瑞马唑仑组的疼痛强度和镇痛药的需要量较低。

结论：基于瑞马唑仑的全凭静脉麻醉提供了与丙泊酚相似的QoR。瑞马唑仑和丙泊酚可互换用于接受甲状腺手术的女性患者全身麻醉。

原始文献来源：

Jeong Yeon Choi，Hye Sun Lee, Ji Young Kim,et al.Comparison of remimazolam-based and propofol-based total intravenous anesthesia on postoperative quality of recovery: A randomized non-inferiority trial [J]. (J Clin Anesth. 2022 Nov;82:110955).

英文原文

Comparison of remimazolam-based and propofol-based total intravenous anesthesia on postoperative quality of recovery: A randomized non-inferiority trial

Abstract

Study objective: The quality of recovery (QoR) of remimazolam-based and propofol-based total intravenous anesthesia was compared as measured by QoR-15 scores.

Design: A prospective, double-blind, randomized controlled, non-inferiority trial.

Setting: An operating room, a post-anesthesia care unit (PACU), and a hospital ward.

Patients: Female patients (n=140; 20–65 years) scheduled for open thyroidectomy were enrolled and randomly assigned to the remimazolam or propofol group.

Interventions: The remimazolam group received continuous remimazolam infusions and effect-site targetcontrolled remifentanil infusions. The propofol group received effect-site target-controlled infusions of propofol and remifentanil.

Measurements: The primary outcome was QoR-15 on postoperative day 1 (POD1). The mean difference between the groups was compared against a non-inferiority margin of −8. Secondary outcomes were QoR-15 on POD2, hemodynamic data, time to lose and recover consciousness, sedation score upon PACU admission, pain, and

postoperative nausea and vomiting profiles at the PACU and ward. Group-time interaction effects in hemodynamic data and QoR-15 were analyzed using a linear mixed model.

Main results: The total QoR-15 score on POD1 in the remimazolam group was non-inferior to that in the propofol group (mean [SD] 111.2 [18.8] vs. 109.1 [18.9]; mean difference [95% CI] 2.1 [−4.2, 8.5]; p=0.002 for noninferiority). The QoR-15 score on POD2 was comparable between the groups, and no group-time interaction was observed. At the end of anesthesia, after extubation, and upon arrival at the PACU, mean arterial pressure was significantly higher in the remimazolam group. Remimazolam group was more sedated at the time of admission to PACU. Pain intensity and the requirement for analgesics were lower in the remimazolam group than in the propofol group.

Conclusions: Remimazolam-based total intravenous anesthesia provided a similar QoR to propofol. Remimazolam and propofol can be used interchangeably for general anesthesia in female patients undergoing thyroid surgery.

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