背景:闪光视觉诱发电位(FVEP)是在神经外科手术中监测术中视觉功能的关键方法。最近,一种名为瑞米唑仑的新型苯二氮卓类药物被用于全身麻醉。然而,瑞咪唑安定对FVEP的影响尚不清楚.因此,我们的目的是研究雷米唑仑,与异丙酚相比,联合0.6%七氟醚麻醉时,影响垂体腺瘤切除术中的FVEP波形。
方法:总的来说,36例全麻下行垂体腺瘤切除术的患者被随机分配到瑞马唑仑组(R组)或丙泊酚组(P组),随机化,控制,非自卑审判。对于麻醉诱导,每次静脉注射0.2mg/kg瑞米唑仑或2mg/kg丙泊酚,持续约1分钟.通过连续输注雷米唑仑(0.7-1.0mg/kg/h)或丙泊酚(4-6mg/kg/h)维持麻醉,与0.6%七氟醚合用,旨在将双频指数(BIS)维持在40-60的范围内。主要结果是插管后约20分钟(T0)记录的FVEP的N75-P100振幅。P组T0时振幅的10%定义为非劣效性边缘(δ)。使用置信区间测试来评估非劣效性假设。次要结局涵盖了FVEP的P100潜伏期,视网膜电图(ERG)b波振幅,人口特征,血流动力学,以及不良事件的发生。
结果:在相同的测量时间点,麻醉期间的BIS指数在两组之间具有可比性(P>0.05)。R组T0时的N75-P100振幅为7.64±1.36µV,而P组为6.96±0.95µV(P=0.09),平均差为0.68µV(95%CI,-0.11µV至1.48µV)。δ设定为0.7,95%CI的下限超过-δ。雷米唑仑和异丙酚对ERGb波振幅影响不大。在指定的时间点,FVEP振幅和P100潜伏期在两组间无明显差异(P>0.05)。此外,与麻醉相关的不良事件发生率无显著差异,针状电极,或手术治疗两组间比较(P>0.05)。
结论:我们的研究结果表明,在全身麻醉中,雷米唑仑-0.6%七氟醚不劣于异丙酚-0.6%七氟醚,基于FVEPN75-P100振幅。两组中获得的电生理数据表明,可以在设定的时间点获得可再现且稳定的FVEP和ERG波形。因此,用于可靠的FVEP监测,雷米唑仑-0.6%七氟醚似乎是一种安全有效的全身麻醉方案.
背景:这项研究在chictr.org上注册。cn(ChiCTR2200056803,17/02/2022)。
BACKGROUND: Flash visual evoked potential (FVEP) is a critical method for monitoring intraoperative visual function during neurosurgery. A new benzodiazepine drug called remimazolam has recently been used for general anesthesia. However, the impact of remimazolam on FVEP remains unclear. Therefore, we aimed to investigate how remimazolam, in comparison to propofol, when combined with 0.6% sevoflurane anesthesia, affects the FVEP waveform during pituitary adenoma resection.
METHODS: Overall, 36 patients undergoing pituitary adenoma resection under general anesthesia were randomly assigned to either the remimazolam group (Group R) or the propofol group (Group P) in a prospective, randomized, controlled, non-inferiority trial. For anesthesia induction, a bolus of 0.2 mg/kg remimazolam or 2 mg/kg propofol was intravenously infused for approximately one minute. The anesthesia was maintained by continuous infusion of either remimazolam (0.7-1.0 mg/kg/h) or propofol (4-6 mg/kg/h), in combination with 0.6% sevoflurane, aimed at sustaining the bispectral index (BIS) within the range of 40-60. The primary outcome was the N75-P100 amplitude of FVEP recorded at approximately 20 min after intubation (T0). 10% of the amplitude at T0 in group P was defined as the non-inferiority margin (δ). Confidence interval testing was used to evaluate the non-inferiority hypothesis. The secondary outcomes covered the P100 latency of FVEP,
electroretinogram (ERG) b wave amplitude, demographic characteristics, hemodynamics, and occurrence of adverse events.
RESULTS: The BIS index during anesthesia was comparable between the groups at the same measured time points (P > 0.05). The N75-P100 amplitude at T0 in group R was 7.64 ± 1.36 µV, while it was 6.96 ± 0.95 µV in group P (P = 0.09), with a mean difference of 0.68 µV (95% CI, -0.11 µV to 1.48 µV). The δ was set at 0.7 and the lower limit of the 95% CI exceeded the -δ. Both remimazolam and propofol had little effect on ERG b-wave amplitudes. At the designated time points, FVEP amplitude and P100 latency displayed no appreciable variation between the two groups (P > 0.05). Furthermore, there were no significant differences in the incidence of adverse events related to anesthesia, needle electrodes, or surgery between the two groups (P > 0.05).
CONCLUSIONS: Our findings suggest that remimazolam-0.6% sevoflurane is non-inferior to propofol-0.6% sevoflurane for general anesthesia, based on the FVEP N75-P100 amplitude. The electrophysiological data obtained in both groups indicate that reproducible and stable FVEP and ERG waveforms can be acquired at set time points. Therefore, for reliable FVEP monitoring, remimazolam-0.6% sevoflurane appears to be a safe and effective protocol in general anesthesia.
BACKGROUND: This study was registered on chictr.org.cn (ChiCTR2200056803, 17/02/2022).