Wong John On-Nin, Tan Thomas Dou-Moo, Leung Pak-On, Tseng Kin-Fui, Cheu Ning-Wei, Tang Chao-Shun
Department of Anesthesiology, St. Martin De Porres Hospital, Chiayi, Taiwan.
Kaohsiung J Med Sci. 2004 Sep;20(9):423-30. doi: 10.1016/S1607-551X(09)70180-9.
We compared the clinical efficacy and safety of two doses of ropivacaine for spinal anesthesia in Chinese patients undergoing lower limb and lower abdominal surgery. In this randomized, open-label study, 40 patients were divided into two groups: group A received 3.5 mL (26.25 mg) of 0.75% glucose-free ropivacaine, and group B received 4.5 mL (33.75 mg). Sensory and motor blocks were assessed during and after surgery through to complete recovery. Seven standard measurements were taken: time to onset of sensory blocks; maximum sensory cephalad spread; time to maximum sensory block; maximum number of blocked segments; duration of sensory block at L3; time to onset of complete motor block; and duration until complete motor block recovery. Vital signs and any adverse effects related to spinal anesthesia were also recorded. No significant differences were found between the two groups: time to onset of sensory block at L3 in group A vs B (2.1 +/- 9.6 vs 1.7 +/- 7.3 minutes), maximum cephalad spread [T4-5 (C3-T11) vs T4 (C3-T8)], maximum number of blocked segments (18.0 +/- 3.4 vs 19.8 +/- 3.7), time to maximum sensory block (34.0 +/- 22.9 vs 26.8 +/- 17.9 minutes), duration of sensory block at L3 (251.2 +/- 34.7 vs 277.3 +/- 51.1 minutes), time to onset of complete motor block (13.4 +/- 6.4 vs 10.3 +/- 3.4 minutes), and time for complete recovery from motor block (264 +/- 52.1 vs 292.5 +/- 64.5 minutes). No significant differences in global hemodynamic changes were found during and after the operation. While shivering was more frequent in group B during the operation, the difference was not significant. Otherwise, there were no differences in adverse effects during and after surgery. We conclude that both doses of 0.75% glucose-free ropivacaine, 26.25 mg (3.5 mL) and 33.75 mg (4.5 mL), have the same efficacy and safety in Chinese patients undergoing spinal anesthesia for lower limb and lower abdominal surgery.
我们比较了两种剂量的罗哌卡因用于中国下肢及下腹部手术患者脊髓麻醉的临床疗效和安全性。在这项随机、开放标签研究中,40例患者被分为两组:A组接受3.5 mL(26.25 mg)的0.75%无葡萄糖罗哌卡因,B组接受4.5 mL(33.75 mg)。在手术期间及术后直至完全恢复过程中评估感觉和运动阻滞情况。进行了七项标准测量:感觉阻滞起效时间;感觉向头端扩散的最大范围;达到最大感觉阻滞的时间;阻滞节段的最大数量;L3水平感觉阻滞持续时间;完全运动阻滞起效时间;以及直至运动阻滞完全恢复的时间。还记录了生命体征以及与脊髓麻醉相关的任何不良反应。两组之间未发现显著差异:A组与B组L3水平感觉阻滞起效时间(2.1±9.6 vs 1.7±7.3分钟)、感觉向头端扩散的最大范围[T4 - 5(C3 - T11)vs T4(C3 - T8)]、阻滞节段的最大数量(18.0±3.4 vs 19.8±3.7)、达到最大感觉阻滞的时间(34.0±22.9 vs 26.8±17.9分钟)、L3水平感觉阻滞持续时间(251.2±34.7 vs 277.3±51.1分钟)、完全运动阻滞起效时间(13.4±6.4 vs 10.3±3.4分钟)以及运动阻滞完全恢复时间(264±52.1 vs 292.5±64.5分钟)。手术期间及术后未发现整体血流动力学变化有显著差异。虽然手术期间B组寒战更频繁,但差异不显著。此外,手术期间及术后不良反应无差异。我们得出结论,对于接受脊髓麻醉进行下肢及下腹部手术的中国患者,26.25 mg(3.5 mL)和33.75 mg(4.5 mL)这两种剂量的0.75%无葡萄糖罗哌卡因具有相同的疗效和安全性。