鞘内给予氯胺酮作为硬膜外罗哌卡因分娩镇痛的辅助药物：一项前瞻性、双盲剂量反应研究。
Esketamine administered epidurally as an adjuvant to epidural ropivacaine for labour analgesia: a prospective, double-blind dose-response study.
机构信息
Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
出版信息
BMJ Open. 2024 Nov 2;14(11):e071818. doi: 10.1136/bmjopen-2023-071818.
OBJECTIVE
To investigate the efficacy of esketamine as an adjuvant to epidural ropivacaine for labour analgesia by determining its effect on the median effective concentration (EC) in a 20 ml volume of ropivacaine.
DESIGN
A prospective, double-blind dose-response study.
SETTING
This study was conducted in Women's Hospital, School of Medicine, Zhejiang University, China.
PARTICIPANTS
One hundred and fifty parturients who requested epidural analgesia were recruited in this study to randomly receive epidural ropivacaine alone or with esketamine of 0.2 mg ml, 0.3 mg ml, 0.4 mg ml or 0.5 mg ml, respectively.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome, EC of ropivacaine, was determined using an up-down sequential allocation technique. The secondary outcomes were analgesia characteristics, Ramsay Sedation Scale score, labour duration, caesarean section rate and adverse effects.
RESULTS
The EC of ropivacaine with the addition of esketamine at concentrations of 0.3 mg ml, 0.4 mg ml and 0.5 mg ml resulted in significant reductions in the EC of ropivacaine to 0.050%, 0.044% and 0.043%, respectively, from baseline (esketamine 0 mg ml) (p<0.0001). However, reductions of the EC of ropivacaine were similar among the groups with esketamine of 0.3 mg ml, 0.4 mg ml and 0.5 mg ml (p>0.05). The Ramsay Sedation Scale score was higher and more dizziness was observed in the Group of esketamine 0.5 mg ml compared with all other groups (p<0.0001). During the peripartum period, no differences in sensory blockade level, Bromage score, labour duration and percentage of caesarean delivery were found among the groups.
CONCLUSIONS
Under the conditions of this study, the addition of epidural esketamine of 0.3 mg⋅mL, 0.4 mg⋅mL and 0.5 mg⋅mL offered a similar ropivacaine dose-sparing effect; 0.5 mg⋅mL of esketamine produced more adverse effects.
TRIAL REGISTRATION NUMBER
ChiCTR2100054348.
目的
通过确定氯胺酮对罗哌卡因 20ml 容量中中效浓度（EC）的影响，研究氯胺酮作为硬膜外罗哌卡因分娩镇痛辅助药物的疗效。
设计
前瞻性、双盲剂量反应研究。
地点
本研究在浙江大学医学院附属妇产科医院进行。
参与者
本研究共招募了 150 名要求硬膜外镇痛的产妇，随机接受单独硬膜外罗哌卡因或分别添加 0.2mg/ml、0.3mg/ml、0.4mg/ml 或 0.5mg/ml 氯胺酮的罗哌卡因。
主要和次要结局测量
主要结局，即罗哌卡因的 EC，采用上下序贯分配技术确定。次要结局为镇痛特征、拉姆齐镇静评分、产程、剖宫产率和不良反应。
结果
添加浓度为 0.3mg/ml、0.4mg/ml 和 0.5mg/ml 的氯胺酮可使罗哌卡因的 EC 分别显著降低至 0.050%、0.044%和 0.043%，与基线（氯胺酮 0mg/ml）相比（p<0.0001）。然而，添加 0.3mg/ml、0.4mg/ml 和 0.5mg/ml 氯胺酮的罗哌卡因 EC 降低情况相似（p>0.05）。与其他组相比，氯胺酮 0.5mg/ml 组的 Ramsay 镇静评分更高，头晕发生率更高（p<0.0001）。在围产期，各组间感觉阻滞水平、Bromage 评分、产程和剖宫产率无差异。
结论
在本研究条件下，硬膜外添加 0.3mg/ml、0.4mg/ml 和 0.5mg/ml 的氯胺酮具有相似的罗哌卡因剂量节约作用；0.5mg/ml 氯胺酮产生更多不良反应。
试验注册号
ChiCTR2100054348。
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