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七氟醚麻醉对脊柱手术患者闪光视觉诱发电位监测的影响:一项随机对照试验的研究方案。

Effect of desflurane anesthesia on flash visual evoked potential monitoring in patients undergoing spine surgery: study protocol for a randomized controlled trial.

机构信息

Department of Anaesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, PR China.

Department of Electrophysiology, Beijing Neurosurgical Institute, Beijing, 100070, People's Republic of China.

出版信息

Trials. 2024 Jun 6;25(1):362. doi: 10.1186/s13063-024-08211-9.

Abstract

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.

METHODS/ DESIGN: 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.

DISCUSSION

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.

TRIAL REGISTRATION

This study was registered on clinicaltrials.gov on July 15, 2022.

CLINICALTRIALS

gov Identifier: NCT05465330.

摘要

背景

闪光视觉诱发电位(FVEP)是一种在俯卧位脊柱手术中保护视觉功能的可靠方法。然而,由于各种麻醉药物对 FVEP 的影响尚不清楚,FVEP 的普及和应用仍然受到限制。探索麻醉药物对 FVEP 的影响,建立合适的麻醉维持方法,对于促进和应用 FVEP 尤为重要。根据传统观念,吸入性麻醉药显著影响 FVEP 监测、提取和解释的成功率。然而,我们之前的研究表明,七氟醚-丙泊酚平衡麻醉是 FVEP 的一种可行方案。地氟醚因其快速恢复的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,本试验将研究不同吸入浓度的地氟醚麻醉对脊柱手术期间 FVEP 振幅的影响,旨在为 FVEP 的临床应用确定更可行的麻醉方案。

方法/设计:本前瞻性、随机对照、开放标签、患者评估者盲法、优效性试验将纳入 70 例择期行脊柱手术的患者,将其随机分为低吸入浓度地氟醚组(LD 组)和高吸入浓度地氟醚组(HD 组),每组各 35 例。所有患者均在术中监测 FVEP,并在全静脉麻醉(TIVA)诱导后半小时测量基线。然后,LD 组患者接受 0.5 最低肺泡浓度(MAC)地氟醚联合丙泊酚和瑞芬太尼维持麻醉,HD 组患者接受 0.7-1.0 MAC 地氟醚和瑞芬太尼维持麻醉。主要结局为麻醉诱导后 1 小时的 N75-P100 振幅。我们打算使用双重测量评估、双重数据录入和由两名经过培训的评估员进行的统计分析,以确保结果的可靠性和准确性。

讨论

本随机对照试验旨在探讨低吸入浓度地氟醚联合丙泊酚-瑞芬太尼平衡麻醉与高吸入浓度地氟醚联合瑞芬太尼麻醉对 FVEP 振幅的优势效果。本研究旨在发表在同行评议的期刊上,并可能为 FVEP 的麻醉方案提供指导。预计该结论将为地氟醚对 FVEP 的影响提供高质量的证据,并旨在探索更可行的 FVEP 临床应用和视觉功能保护的麻醉方案。

试验注册

本研究于 2022 年 7 月 15 日在 clinicaltrials.gov 上注册。

临床试验.gov 标识符:NCT05465330。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87c4/11155073/c526592d623f/13063_2024_8211_Fig1_HTML.jpg

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