电视辅助胸腔镜手术肺叶切除术中罗哌卡因-舒芬太尼的最佳程序化间歇性硬膜外推注间隔时间：一项关于罗哌卡因-舒芬太尼的偏倚硬币上下法研究
Optimal Programmed Intermittent Epidural Bolus Interval for Video-Assisted Thoracic Surgery Lobectomy: A Biased-Coin Up-Down Study of Ropivacaine-Sufentanil.
作者信息
Feng Chengfei, Wen Jijin, Lai Guozhong, Lu Xiaofan, Luo Guanli, Lu Yali, Li Wei, Lai Renchun
机构信息
Department of Anesthesiology, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangdong Provincial Key Laboratory of Ophthalmology Visual Science, Guangdong Provincial Clinical Research Center for Ocular Disease, Guangzhou, 510060, People's Republic of China.
Department of Anesthesiology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, People's Republic of China.
出版信息
Drug Des Devel Ther. 2025 Aug 20;19:7207-7214. doi: 10.2147/DDDT.S538163. eCollection 2025.
PURPOSE
Programmed intermittent epidural bolus (PIEB) is a novel epidural anesthesia technique for video-assisted thoracic surgery (VATS). However, the optimal setting of the PIEB parameters remains to be determined. This study aimed to determine the optimal time interval for the PIEB regimen of 10 mL ropivacaine 0.15% with sufentanil 0.4 μg/mL within 24 hours of VATS lobectomy.
PATIENTS AND METHODS
We conducted a double-blind, sequential allocation trial with a biased-coin up-down design. 42 patients scheduled for VATS lobectomy were enrolled in the study. All participants received a fixed programmed bolus dose of 10 mL of 0.15% ropivacaine combined with 0.4 μg/mL sufentanil. The PIEB interval was initially set at 180 minutes for the first patient and adjusted for subsequent patients according to the biased-coin design, with intervals of 180, 150, 120, and 90 minutes (corresponding to groups 180, 150, 120, and 90, respectively). The primary outcome was the achievement of effective analgesia, defined as the absence of any requirement for patient-controlled epidural analgesia (PCEA) or additional rescue analgesic interventions within 24 hours after the loading dose. Secondary outcomes included the documentation of postoperative adverse effects, such as nausea, vomiting, hypotension, pruritus, and dizziness.
RESULTS
A total of 40 patients were included in the study. Using Isotonic Regression analysis, the estimated effective interval for 90% (EI90) of patients was determined to be 97.4 minutes (95% confidence interval [CI]: 91.6-103.1 minutes). The incidence of postoperative hypotension varied significantly across groups, with the highest probability observed in group 90 (64.3%), followed by group 120 (18.8%) and group 150 (11.1%).
CONCLUSION
The estimated effective interval for the EI90 between PIEB of 10 mL of ropivacaine 0.15% with sufentanil 0.4 μg/mL was approximately 100 minutes.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR2300077174.
目的
程序化间歇性硬膜外推注（PIEB）是一种用于电视辅助胸腔镜手术（VATS）的新型硬膜外麻醉技术。然而，PIEB参数的最佳设置仍有待确定。本研究旨在确定在VATS肺叶切除术后24小时内，10 mL 0.15%罗哌卡因与0.4 μg/mL舒芬太尼的PIEB方案的最佳时间间隔。
患者与方法
我们采用偏倚硬币上下设计进行了一项双盲、序贯分配试验。42例计划行VATS肺叶切除术的患者纳入本研究。所有参与者均接受固定的程序化推注剂量，即10 mL 0.15%罗哌卡因与0.4 μg/mL舒芬太尼联合使用。第一名患者的PIEB间隔最初设定为180分钟，后续患者根据偏倚硬币设计进行调整，间隔分别为180、150、120和90分钟（分别对应180、150、120和90组）。主要结局是实现有效镇痛，定义为在负荷剂量后24小时内无需患者自控硬膜外镇痛（PCEA）或额外的补救镇痛干预措施。次要结局包括记录术后不良反应，如恶心、呕吐、低血压、瘙痒和头晕。
结果
本研究共纳入40例患者。采用等渗回归分析，确定90%患者的估计有效间隔（EI90）为97.4分钟（95%置信区间[CI]：91.6 - 103.1分钟）。术后低血压的发生率在各组间差异显著，90组观察到的概率最高（64.3%），其次是120组（18.8%）和150组（11.1%）。
结论
10 mL 0.15%罗哌卡因与0.4 μg/mL舒芬太尼的PIEB之间的EI90估计有效间隔约为100分钟。
试验注册
中国临床试验注册中心，ChiCTR2300077174。
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