碳酸氢钠林格液与乳酸林格液对幕上肿瘤切除术患者苏醒时间的影响：一项随机对照试验。
完整摘要 · 中文译文
背景：在神经麻醉中，麻醉后迅速苏醒对术后神经功能评估至关重要。术中输注碳酸氢钠林格液（BRS）与乳酸林格液（LRS）对内环境的影响不同，可能导致恢复情况的差异。因此，本研究旨在比较BRS与LRS在幕上肿瘤开颅手术患者中的恢复情况。 方法：本随机对照试验纳入择期行幕上肿瘤切除术的患者。患者被随机分配接受BRS或LRS进行术中液体治疗。主要结局为苏醒时间。次要结局包括拔管时间、拔管后15分钟简明定向记忆专注力测试（SOMCT）及术后并发症。在多个时间点测定乳酸（Lac）、pH、碱剩余（BE）和血清Mg2+水平等参数并在两组间进行比较。同时记录总住院时间并在两组间进行比较。主要分析遵循意向性治疗（ITT）原则。对主要结局还进行了符合方案集（PP）敏感性分析。 结果：ITT分析纳入100例患者（BRS组：n=50；LRS组：n=50）。排除手术时间过短或术中大量失血的病例后，PP集包括48例BRS组患者和47例LRS组患者。在ITT分析中，分配至BRS组的患者苏醒时间更短（13min vs 16min；中位数差值，3；95% CI，1至4；P=0.003） ) 以及拔管时间（15分钟 vs 18分钟；中位差，2；95% CI，1～4；P=0.01）更短，手术结束时及拔管后0.5小时的乳酸水平更低（P < 0.05）。两组间拔管后15分钟的SOMCT评分、术后并发症和总住院天数相当（P > 0.05）。此外，pH、BE和Mg²⁺水平未发现显著的组别×时间交互作用，表明两组间的时间变化趋势相似（P > 0.05）。 结论：幕上肿瘤切除术中接受BRS的患者苏醒更快、拔管时间更短，但拔管后15分钟的SOMCT评分和并发症发生率与接受LRS的患者相似。 试验注册：中国临床试验注册中心，ChiCTR2500105691，注册日期2025年7月9日。
完整摘要 · 英文原文
BACKGROUND: In neuroanesthesia, a prompt emergence from anesthesia is essential for postoperative neurologic assessment. Intraoperative infusion of sodium bicarbonate Ringer's solution (BRS) and lactated Ringer's solution (LRS) have different effects on internal environment, potentially contributing to discrepant recovery profiles. Therefore, this study aimed to compare the recovery of BRS and LRS in patients undergoing craniotomy for supratentorial tumors. METHODS: This randomized controlled trial enrolled patients undergoing elective supratentorial tumor resection. Patients were randomized to receive BRS or LRS for intraoperative fluid therapy. The primary outcome was emergence time. Secondary outcomes included extubation times, short Orientation Memory Concentration Test (SOMCT) at 15 min after extubation and postoperative complications. Parameters including lactic acid (Lac), pH, base excess (BE), and serum Mg2+ levels were measured at several time points and compared between the two groups. Total length of hospital stay was also recorded and compared between the two groups. Primary analysis followed the intention-to-treat (ITT) principle. A per-protocol (PP) sensitivity analysis was also performed for the primary outcome. RESULTS: The ITT analysis included 100 patients (BRS group: n = 50; LRS group: n = 50). Following exclusions for short surgery or massive intraoperative blood loss, the PP set included 48 BRS and 47 LRS patients. In the ITT analysis, Patients assigned to the BRS group had shorter emergence (13min vs 16min; median difference, 3; 95% CI, 1 to 4; P=0.003) and extubation times (15min vs 18min; median difference, 2; 95% CI, 1 to 4; P=0.01), and lower lactate levels at the end of surgery and 0.5 hour after extubation (P < 0.05). SOMCT scores at 15 min after extubation, postoperative complications and total hospitalization days were comparable between the groups (P > 0.05). Additionally, no significant group-by-time interactions were found for pH, BE and Mg2⁺ levels, indicating similar temporal changes between groups (P > 0.05). CONCLUSION: Patients receiving BRS during supratentorial tumor resection had faster emergence and shorter extubation times, but similar SOMCT scores at 15 min after extubation and complication rates compared to those receiving LRS. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2500105691, registered on July 9, 2025.