舒泰安定与阿芬太尼用于宫腔镜检查的比较：一项前瞻性、双盲、随机对照试验。
Comparison Between Esketamine and Alfentanil for Hysteroscopy: A Prospective, Double-Blind, Randomized Controlled Trial.
机构信息
Department of Anesthesiology, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, Zhejiang, People's Republic of China.
Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, People's Republic of China.
出版信息
Drug Des Devel Ther. 2024 Aug 14;18:3629-3641. doi: 10.2147/DDDT.S472651. eCollection 2024.
PURPOSE
This study aimed to establish the 95% effective dose (ED95) of esketamine in combination with propofol for hysteroscopy and then to evaluate its efficacy and safety profile.
PATIENTS AND METHODS
This prospective, double-blind, randomized controlled trial consisted of two cohorts. In cohort 1, 45 women aged 18-65 years undergoing hysteroscopy were randomly assigned to either group E (esketamine + propofol) or group A (alfentanil + propofol). Dixon's up-and-down method was used to determine the ED95 of esketamine and alfentanil. In cohort 2, 86 patients were randomized to group E and group A, with the calculated ED95 dose of the study drugs used for induction. The success rate of anesthesia using the ED95% dose, along with parameters related to anesthesia induction, recovery, and adverse events were also recorded.
RESULTS
The ED95 of esketamine was 0.254 mg/kg (95% CI: 0.214-1.004), while that of alfentanil was 9.121 μg/kg (95% CI: 8.479-13.364). The anesthesia success rate was 93.0% in group E and 95.2% in group A (p = 0.664). After resuscitation, both groups achieved a 100% success rate. The induction time was significantly shorter in group E (60.0 [55.0-70.0] s) compared to group A (67.0 [61.0-79.3] s) (p = 0.006). Group E had lower rates of respiratory depression (p < 0.001), hypoxia (p = 0.006), minimum perioperative SpO (p = 0.010), and hypotension (p = 0.001). Esketamine had less effect on respiratory rate, heart rate, mean blood pressure, and end-tidal carbon dioxide compared to alfentanil (all p < 0.001). There were no significant differences in postoperative pain between the two groups.
CONCLUSION
This study determined the ED 95 dose of esketamine for intravenous general anesthesia during hysteroscopy. Esketamine showed less respiratory and hemodynamic depression, as well as fewer adverse effects compared to alfentanil. Esketamine is an ideal anesthetic agent compared to alfentanil for hysteroscopic anesthesia.
TRIAL REGISTRATION
www.chictr.org.cn, (ChiCTR2300077283); registered November 3, 2023.
目的
本研究旨在确定氯胺酮联合丙泊酚用于宫腔镜检查的 95%有效剂量（ED95），并评估其疗效和安全性。
患者和方法
这是一项前瞻性、双盲、随机对照试验，包括两个队列。在队列 1 中，45 名年龄在 18-65 岁之间的行宫腔镜检查的女性被随机分配到 E 组（氯胺酮+丙泊酚）或 A 组（阿芬太尼+丙泊酚）。采用 Dixon 上下法确定氯胺酮和阿芬太尼的 ED95。在队列 2 中，86 名患者被随机分配到 E 组和 A 组，使用研究药物的计算 ED95 剂量进行诱导。记录使用 ED95%剂量的麻醉成功率、麻醉诱导、恢复相关参数以及不良反应。
结果
氯胺酮的 ED95 为 0.254mg/kg（95%CI：0.214-1.004），阿芬太尼的 ED95 为 9.121μg/kg（95%CI：8.479-13.364）。E 组麻醉成功率为 93.0%，A 组为 95.2%（p=0.664）。复苏后，两组均达到 100%的成功率。E 组的诱导时间明显短于 A 组（60.0[55.0-70.0]s）（p=0.006）。E 组呼吸抑制（p<0.001）、缺氧（p=0.006）、最小围手术期 SpO（p=0.010）和低血压（p=0.001）发生率较低。与阿芬太尼相比，氯胺酮对呼吸频率、心率、平均血压和呼气末二氧化碳的影响较小（均 p<0.001）。两组术后疼痛无显著差异。
结论
本研究确定了氯胺酮在宫腔镜检查中静脉全身麻醉的 ED95 剂量。与阿芬太尼相比，氯胺酮显示出较少的呼吸和血液动力学抑制，以及较少的不良反应。与阿芬太尼相比，氯胺酮是宫腔镜麻醉的理想麻醉药物。
试验注册
www.chictr.org.cn（ChiCTR2300077283）；2023 年 11 月 3 日注册。
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