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环丙酚与丙泊酚全凭静脉麻醉对面神经显微血管减压术中的神经生理监测影响的比较: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:柏雪 编辑:杨荣峰 审校:曹莹
环丙酚是一种新研发的短效γ-氨基丁酸受体激动剂,其效价高于丙泊酚。环丙酚作为一种新型镇静药物,临床研究相对较少。本研究旨在评估环丙酚用于神经外科手术中神经电生理监测(IONM)时的安全性和有效性。
本项单中心、非劣效性、单盲随机对照试验于2022年9月13日至2023年9月22日进行。120例接受选择性微血管减压术(MVD)并进行IONM的患者,随机分为环丙酚组与丙泊酚组。该研究的主要结果为术中复合肌动作电位下降的幅度,次要结果包括神经生理监测及麻醉相关指标。
环丙酚组和丙泊酚组的主要结果平均值分别为64.7±44.1和53.4±35.4。此外,差异的95%置信区间为- 25.78 ~ 3.12,差异上限低于非劣效性边界6.6。环丙酚在MVD的IONM中表现出与丙泊酚相当的非劣效性。麻醉诱导期间,环丙酚组的血压下降幅度和注射痛的发生率显著低于丙泊酚组(P<0.05)。此外,环丙酚组的镇静药物和去甲肾上腺素的用量显著低于丙泊酚组(P<0.05)。
环丙酚在IONM中的有效性和安全性不差于丙泊酚。同时,环丙酚在减少注射疼痛和改善血流动力学稳定性方面表现更优,可能更适合IONM相关手术,具有广泛的应用前景。
原始文献来源:Tao Zhu, Fang Kang, Ming-Ming Han, et al. Comparison of Ciprofol-Based and Propofol-Based Total Intravenous Anesthesia on Microvascular Decompression of Facial Nerve with Neurophysiological Monitoring: A Randomized Non-Inferiority Trial[J]. Drug Design, Development and Therapy 2024:18 2475–2484
Comparison of Ciprofol-Based and Propofol-Based T otal Intravenous Anesthesia on Microvascular Decompression of Facial Nerve with Neurophysiological Monitoring: A Randomized Non-Inferiority Trial
Purpose: Ciprofol is a recently developed short-acting gamma-aminobutyric acid receptor agonist with a higher potency than that of propofol. As a new sedative drug, there are few clinical studies on ciprofol. We sought to examine the safety and efficacy of ciprofol use for general anesthesia in neurosurgical individuals undergoing neurosurgical surgery with intraoperative neurophysiological monitoring (IONM).
Patients and Methods: This single-center, non-inferiority, single-blind, randomized controlled trial was conducted from September 13, 2022 to September 22, 2023. 120 patients undergoing elective microvascular decompression surgery (MVD) with IONM were randomly assigned to receive either ciprofol or propofol. The primary outcome of this study was the amplitude of intraoperative compound muscle action potential decline, and the secondary outcome included the indexes related to neurophysiological monitoring and anesthesia outcomes.
Results: The mean values of the primary outcome in the ciprofol group and the propofol group were 64.7±44.1 and 53.4±35.4, respectively. Furthermore, the 95% confidence interval of the difference was −25.78 to 3.12, with the upper limit of the difference being lower than the non-inferiority boundary of 6.6. Ciprofol could achieve non-inferior effectiveness in comparison with propofol in IONM of MVD. The result during anesthesia induction showed that the magnitude of the blood pressure drop and the incidence of injection pain in the ciprofol group were significantly lower than those in the propofol group (P<0.05). The sedative drug and norepinephrine consumption in the ciprofol group was significantly lower than that in the propofol group (P<0.05).
Conclusion: Ciprofol is not inferior to propofol in the effectiveness and safety of IONM and the surgical outcome. Concurrently, ciprofol is more conducive to reducing injection pain and improving hemodynamic stability, which may be more suitable for IONM- related surgery, and has a broad application prospect.
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