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艾司氯胺酮预防腰麻-硬膜外联合麻醉下剖宫产术中卡前列素引起的不良反应:一项双盲随机试验

Esketamine prevents carboprost-induced adverse reactions during cesarean section under combined spinal-epidural anesthesia: a double-blind, randomized trial.

作者信息

Zhou Feng, Ma Qingling, Meng Fanqing, Bao Han, Liu Wei, Zhang Guangfen, Tian Yue

机构信息

Department of Anesthesiology, Shengjing Hospital of China Medical University, No. 36, Sanhao Street, Heping District, Shenyang, Liaoning, 110004, P.R. China.

Department of Anesthesiology, Jinan Maternity and Child Care Hospital, Shandong First Medical University, Jinan, China.

出版信息

BMC Anesthesiol. 2025 Jul 12;25(1):345. doi: 10.1186/s12871-025-03173-0.

Abstract

OBJECTIVES

To investigate adverse reactions to carboprost reduced by intravenous esketamine administered after childbirth via cesarean delivery with the patient under combined spinal-epidural anesthesia.

METHODS

The study enrolled pregnant women aged 20-40 years, with American Society of Anesthesiologists (ASA) class II or III, and a gestational age of 37 weeks or more. These women had a scheduled cesarean section procedure with the administration of combined spinal-epidural anesthesia. Patients were randomized to receive esketamine 0.5 mg/kg (Group E) or volume-matched normal saline (Group C) immediately after fetal delivery, prior to carboprost administration (250 µg intramuscularly). The primary outcome was the incidence of vomiting during surgery. The secondary outcomes were the incidence of adverse reactions (nausea, chest rigidity, flushed face, tachycardia, cough, shivering), vital signs (HR, RR, MAP, SPO) and postoperative pain assessed using a Visual Analogue Scale (VAS).

RESULTS

Eighty-one pregnant women completed the study. The incidence of vomiting (22.5% vs. 56.1%, p < 0.001) and the incidence of nausea, chest rigidity, flushed face, and hypertension were significantly lower in group E than in group C (all p < 0.01), but the incidence of tachycardia was higher in group E (45% vs. 19.5%, p < 0.001). Furthermore, the patients' arterial partial pressure of oxygen was significantly higher in group E than in group C (91.90 ± 5.14 vs. 79.76 ± 3.96, p < 0.001). Postoperative pain at the incision site, as assessed by Visual Analogue Scale (VAS) score, was significantly reduced at 6 h in the Esketamine group compared to the control group. However, there was no significant difference in uterine contraction pain between the two groups at any time point.

CONCLUSION

For women undergoing cesarean delivery under combined spinal-epidural anesthesia, intravenous esketamine administered after delivery of the fetus and prior to carboprost administration during cesarean section under combined spinal - epidural anesthesia was associated with a reduction in the incidence of carboprost - induced adverse reactions and a decrease in postoperative incision pain at 6 h. However, it did not significantly affect postoperative uterine contraction pain.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (Registration number# ChiCTR2100054985); Date of Registration: 30/12/2021.

摘要

目的

探讨在腰麻-硬膜外联合麻醉下剖宫产术后静脉注射艾司氯胺酮以减少卡前列素的不良反应。

方法

本研究纳入年龄在20-40岁、美国麻醉医师协会(ASA)分级为II或III级、孕周37周及以上的孕妇。这些孕妇计划进行腰麻-硬膜外联合麻醉下的剖宫产手术。患者在胎儿娩出后、卡前列素给药(250μg肌肉注射)前,随机接受0.5mg/kg艾司氯胺酮(E组)或等容量生理盐水(C组)。主要结局是手术期间呕吐的发生率。次要结局是不良反应(恶心、胸壁僵硬、面部潮红、心动过速、咳嗽、寒战)的发生率、生命体征(心率、呼吸频率、平均动脉压、血氧饱和度)以及使用视觉模拟评分法(VAS)评估的术后疼痛。

结果

81名孕妇完成了研究。E组呕吐发生率(22.5%对56.1%,p<0.001)以及恶心、胸壁僵硬、面部潮红和高血压的发生率显著低于C组(均p<0.01),但E组心动过速的发生率更高(45%对19.5%,p<0.001)。此外,E组患者的动脉血氧分压显著高于C组(91.90±5.14对79.76±3.96,p<0.001)。与对照组相比,艾司氯胺酮组在术后6小时通过视觉模拟评分法(VAS)评估的切口部位疼痛明显减轻。然而,两组在任何时间点的子宫收缩疼痛均无显著差异。

结论

对于在腰麻-硬膜外联合麻醉下进行剖宫产的女性,在腰麻-硬膜外联合麻醉下剖宫产术中胎儿娩出后、卡前列素给药前静脉注射艾司氯胺酮与卡前列素引起的不良反应发生率降低以及术后6小时切口疼痛减轻有关。然而,它对术后子宫收缩疼痛没有显著影响。

试验注册

中国临床试验注册中心(注册号# ChiCTR2100054985);注册日期:2021年12月30日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5a3/12255002/21b0d55bf5c5/12871_2025_3173_Fig1_HTML.jpg

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