可谱诺〔盐酸氯普鲁卡因〕用于产科硬膜外麻醉的.doc

氯普鲁卡因用于产科硬膜外麻醉多中心临床研究 杨东 姚尚龙 傅润乔 徐铭军 沈晓【摘要】目的 采用多中心、随机、双盲、平行对照的方法评价国产盐酸氯普鲁卡因用于剖宫产手术硬膜外麻醉的效果和安全性。方法 来自四家医院的硬膜外麻醉下行择期剖宫产手术病人160例， ASA分级Ⅰ-Ⅱ级，随机分为试验组（）和对照组（利多卡因），每组80例。选择腰2-3间隙行硬膜外穿刺置管，试验剂量5ml，无脊麻现象或毒性反应，五分钟后追加12ml。以第二次给药作为起始时间点，记录麻醉起效时间、痛觉消失时间、最高阻滞平面及时间、痛觉恢复时间、运动恢复时间；评价手术肌松效果；记录麻醉前、麻醉后5min、10min、15min、20min、30min的血压、心率和SpO2；术中麻黄碱用量；新生儿出生1分钟、5分钟、10分钟的Apgar评分；缩宫素用量和子宫收缩情况以及不良事件的发生情况。结果 试验组的麻醉起效时间、痛觉消失时间、最高阻滞平面及时间与对照组相比没有显著性差异，而试验组的痛觉恢复时间、运动恢复时间较对照组短，两组间有显著性差异P＜0.05；两组间手术肌松效果总体满意度高，无显著性差异；在麻醉前、麻醉后5min、10min、15min、20min、30min两组间的血压、心率和SpO2比较无显著性差异；两组间的术中麻黄碱用量比较无显著性差异；新生儿出生1分钟、5分钟、10分钟的Apgar评分、缩宫素用量和子宫收缩情况，两组比较无显著性差异；两组都没有严重的不良事件发生。结论 盐酸氯普鲁卡因用于产科硬膜外麻醉，与利多卡因麻醉效果满意度相近，无严重不良反应，而且恢复更快，更安全。 【关键词】盐酸氯普鲁卡因利多卡因硬膜外Efficacy and Safety of Chloroprocaine Hydrochloride in Obstetric Epidural Blockage: A Multiple-Center, Randomized, Double-blind, Parallel Study YANG Dong, YAO Shanglong, FU Yunqiao, XU Mingjun, SHEN Xiaofeng, XU Jianguo [Abstract] Objective: To evaluate efficacy and safety of chloroprocaine hydrochloride in obstetric epidural blockage in a multiple-center, randomized, double-blind, parallel study. Method: 160 patients undergoing cesarean section with epidural blockage enrolled from 4 hospitals, ASA gradeⅠ-Ⅱ, were randomly and double-blindly divided into 2 groups: chloroprocaine hydrochloride group(n=80) versus lidocaine group(control group, n=80). The L2-3 epidural space were punctured and epidural tube were inserted. Then all patients were given 3ml of 3% chloroprocaine hydrochloride or 2% lidocaine as test dose, respectively. If there were no signs and symptoms of spinal anesthesia or toxic systemic effect, 12ml 3% chloroprocaine hydrochloride or 2% lidocaine were given five minutes later. The onset times of cold free and pain free, the peak block height and it’s onset time, the recovery times of pain and motor were recorded; vital signs (including BP、HR and SpO2) at the beginning of anesthesia and 5min、10min、15min、20min 、30min later were recorded, as well as