背景:闪光视觉诱发电位(FVEP)是在俯卧位脊柱手术期间保护视觉功能的可靠方法。然而,由于各种麻醉药对FVEP的影响尚不清楚,FVEP的推广应用仍然有限。探讨麻醉药物对FVEP的影响,建立适宜的麻醉维持方法,对FVEP的推广应用尤为重要。按照传统的概念,吸入麻醉药品显著影响FVEP监测的成功,FVEP提取,和解释。尽管如此,我们之前的研究表明,七氟醚-丙泊酚平衡麻醉是FVEP的可行方案.地氟醚因其快速恢复特性而广泛应用于全身麻醉。由于地氟醚对FVEP的影响尚不清楚,本试验将探讨不同吸入浓度地氟醚麻醉对脊柱手术中FVEP振幅的影响,旨在为FVEP的临床应用寻找更可行的麻醉方案。
■共有70名接受择期脊柱手术的患者将被纳入这项前瞻性研究,随机对照,开放标签,患者-评估者-盲,优势试验,并随机分配到低吸入浓度地氟醚组(LD组)维持地氟醚-丙福瑞芬太尼平衡麻醉或高吸入浓度地氟醚组(HD组)维持地氟醚-瑞芬太尼麻醉维持比例为1:1的组。将监测所有患者的术中FVEP,和基线将在全静脉麻醉(TIVA)诱导后半小时测量。之后,LD组患者将接受0.5最低肺泡浓度(MAC)的地氟醚复合丙泊酚和瑞芬太尼用于麻醉维持,而HD组将维持0.7-1.0MAC的地氟醚和瑞芬太尼。主要结果是麻醉诱导后1小时的N75-P100振幅。我们打算使用双重度量评估,双数据输入,并由受过双重培训的评估人员进行统计分析,以确保结果的可靠性和准确性。
结论:本随机对照试验旨在探讨低吸入浓度地氟醚复合丙福芬太尼平衡麻醉与高吸入浓度地氟醚复合瑞芬太尼麻醉对FVEP振幅的优越性。该研究旨在发表在同行评审的期刊上,并可能指导FVEP的麻醉方案。该结论有望为地氟醚对FVEP的影响提供高质量的证据,旨在为FVEP的临床应用及视功能保护探索更可行的麻醉方案。
背景:这项研究于2022年7月15日在clinicaltrials.gov上注册。
结果:gov标识符:NCT05465330。
BACKGROUND: Flash visual evoked potentials (FVEPs) are a reliable method for protecting visual function during spine surgery in prone position. However, the popularization and application of FVEPs remain limited due to the unclear influence of various anesthetics on FVEPs. Exploring the effects of anesthetic drugs on FVEP and establishing appropriate anesthesia maintenance methods are particularly important for promoting and applying FVEP. According to the conventional concept, inhaled narcotic drugs significantly affect the success of FVEP monitoring, FVEP extraction, and interpretation. Nonetheless, our previous
study demonstrated that sevoflurane-propofol balanced anesthesia was a practicable regimen for FVEPs. Desflurane is widely used in general anesthesia for its rapid recovery properties. As the effect of desflurane on FVEP remains unclear, this
trial will investigate the effect of different inhaled concentrations of desflurane anesthesia on amplitude of FVEPs during spine surgery, aiming to identify more feasible anesthesia schemes for the clinical application of FVEP.
UNASSIGNED: A total of 70 patients undergoing elective spinal surgery will be enrolled in this prospective, randomized controlled, open-label, patient-assessor-blinded, superiority trial and randomly assigned to the low inhaled concentration of desflurane group (LD group) maintained with desflurane-propofolremifentanil-balanced anesthesia or high inhaled concentration of desflurane group (HD group) maintained with desflurane-remifentanil anesthesia maintenance group at a ratio of 1:1. All patients will be monitored for intraoperative FVEPs, and the baseline will be measured half an hour after induction under total intravenous anesthesia (TIVA). After that, patients will receive 0.5 minimum alveolar concentration (MAC) of desflurane combined with propofol and remifentanil for anesthesia maintenance in the LD group, while 0.7-1.0 MAC of desflurane and remifentanil will be maintained in the HD group. The primary outcome is the N75-P100 amplitude 1 h after the induction of anesthesia. We intend to use the dual measure evaluation, dual data entry, and statistical analysis by double trained assessors to ensure the reliability and accuracy of the results.
CONCLUSIONS: This randomized controlled
trial aims to explore the superiority effect of low inhaled concentration of desflurane combined with propofolremifentanil-balanced anesthesia versus high inhaled concentration of desflurane combined with remifentanil anesthesia on amplitude of FVEPs. The
study is meant to be published in a peer-reviewed journal and might guide the anesthetic regimen for FVEPs. The conclusion is expected to provide high-quality evidence for the effect of desflurane on FVEPs and aim to explore more feasible anesthesia schemes for the clinical application of FVEPs and visual function protection.
BACKGROUND: This
study was registered on clinicaltrials.gov on July 15, 2022.
RESULTS: gov Identifier: NCT05465330.