Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
Department of Research Affairs, Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Clin Anesth. 2022 Nov;82:110955. doi: 10.1016/j.jclinane.2022.110955. Epub 2022 Aug 25.
The quality of recovery (QoR) of remimazolam-based and propofol-based total intravenous anesthesia was compared as measured by QoR-15 scores.
A prospective, double-blind, randomized controlled, non-inferiority trial.
An operating room, a post-anesthesia care unit (PACU), and a hospital ward.
Female patients (n = 140; 20-65 years) scheduled for open thyroidectomy were enrolled and randomly assigned to the remimazolam or propofol group.
The remimazolam group received continuous remimazolam infusions and effect-site target-controlled remifentanil infusions. The propofol group received effect-site target-controlled infusions of propofol and remifentanil.
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.
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 non-inferiority). 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.
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.
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。
前瞻性、双盲、随机对照、非劣效性试验。
手术室、麻醉后监护病房（PACU）和医院病房。
择期行甲状腺切除术的女性患者（n=140；20-65 岁），纳入并随机分配至瑞马唑仑或丙泊酚组。
瑞马唑仑组接受持续瑞马唑仑输注和效应部位靶控瑞芬太尼输注。丙泊酚组接受效应部位靶控输注丙泊酚和瑞芬太尼。
主要结局为术后第 1 天（POD1）的 QoR-15。组间平均差异与-8 的非劣效性边界进行比较。次要结局为 POD2 的 QoR-15、血流动力学数据、意识丧失和恢复时间、PACU 入院时镇静评分、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 的组-时间交互效应。
瑞马唑仑组 POD1 的总 QoR-15 评分不劣于丙泊酚组（平均[标准差]111.2[18.8] vs. 109.1[18.9]；平均差异[95%CI]2.1[-4.2, 8.5]；p=0.002 用于非劣效性）。两组 POD2 的 QoR-15 评分相当，未观察到组-时间交互作用。麻醉结束时、拔管后和到达 PACU 时，瑞马唑仑组的平均动脉压明显更高。瑞马唑仑组在 PACU 入院时镇静程度更高。瑞马唑仑组的疼痛强度和镇痛需求低于丙泊酚组。
瑞马唑仑全凭静脉麻醉与丙泊酚提供相似的 QoR。瑞马唑仑和丙泊酚可在接受甲状腺手术的女性患者中互换用于全身麻醉。
