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瑞马唑仑与咪达唑仑预防腰麻下剖宫产术中恶心呕吐的比较:一项随机对照试验

Comparison of remimazolam and midazolam for preventing intraoperative nausea and vomiting during cesarean section under spinal anesthesia: a randomized controlled trial.

作者信息

Lee Kyuho, Choi Seung Ho, Kim Sangil, Kim Hae Dong, Oh Hyejin, Kim Seung Hyun

机构信息

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

Department of Anesthesiology and Pain Medicine, MINT Hospital, Seoul, Korea.

出版信息

Korean J Anesthesiol. 2024 Dec;77(6):587-595. doi: 10.4097/kja.24311. Epub 2024 Oct 8.

DOI:10.4097/kja.24311
PMID:39376062
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11637588/
Abstract

BACKGROUND

Preventing intraoperative nausea and vomiting (IONV) is crucial for maternal safety during cesarean section under spinal anesthesia. While midazolam is known to prevent IONV, we hypothesized that remimazolam would be superior due to its minimal hemodynamic effects. We compared the effects of the two drugs on IONV.

METHODS

Parturients scheduled for cesarean section were randomly assigned to receive either midazolam or remimazolam. They received midazolam 2 mg or remimazolam 5 mg, with additional doses administered upon request. The primary outcome measure was the incidence of newly developed IONV during sedation. Other outcomes included overall IONV, rescue antiemetic use, shivering, hemodynamic variables, sedation scale scores, and satisfaction scores.

RESULTS

Data from 80 participants were analyzed. Deeper sedation was induced in the remimazolam group (PGroup × Time < 0.001) despite comparable hemodynamic trends between the groups. The incidence of overall IONV was comparable between the two groups (27.5% in the midazolam group vs. 17.5% in the remimazolam group, absolute risk reduction [ARR]: 0.100, 95% CI [-0.082, 0.282], P = 0.284); however, newly developed IONV during sedation was significantly reduced in the remimazolam group (20.0% vs. 5.0%, ARR: 0.150, 95% CI [0.009, 0.291], P = 0.043). The need for rescue antiemetics was also lower in the remimazolam group (15.0% vs. 2.5%, ARR: 0.125, 95% CI [0.004, 0.246], P = 0.048).

CONCLUSION

Remimazolam significantly reduced the incidence and severity of newly developed IONV compared with midazolam, with minimal impact on hemodynamics, making it a useful sedative option for cesarean section.

摘要

背景

预防术中恶心呕吐(IONV)对于脊髓麻醉下剖宫产术中产妇的安全至关重要。虽然已知咪达唑仑可预防IONV,但我们推测瑞米唑仑因其对血流动力学影响极小而更具优势。我们比较了两种药物对IONV的影响。

方法

计划行剖宫产的产妇被随机分配接受咪达唑仑或瑞米唑仑。她们分别接受2毫克咪达唑仑或5毫克瑞米唑仑,并根据需要给予额外剂量。主要结局指标是镇静期间新发生的IONV的发生率。其他结局包括总体IONV、抢救性止吐药的使用、寒战、血流动力学变量、镇静量表评分和满意度评分。

结果

分析了80名参与者的数据。尽管两组之间的血流动力学趋势相当,但瑞米唑仑组诱导的镇静更深(组×时间<0.001)。两组总体IONV的发生率相当(咪达唑仑组为27.5%,瑞米唑仑组为17.5%,绝对风险降低[ARR]:0.100,95%置信区间[-0.082,0.282],P = 0.284);然而,瑞米唑仑组在镇静期间新发生的IONV显著降低(20.0%对5.0%,ARR:0.150,95%置信区间[0.009,0.291],P = 0.043)。瑞米唑仑组对抢救性止吐药的需求也较低(15.0%对2.5%,ARR:0.125,95%置信区间[0.004,0.246],P = 0.048)。

结论

与咪达唑仑相比,瑞米唑仑显著降低了新发生的IONV的发生率和严重程度,对血流动力学影响极小,使其成为剖宫产术中一种有用的镇静选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bad8/11637588/48d259c913d9/kja-24311f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bad8/11637588/803876de8017/kja-24311f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bad8/11637588/48d259c913d9/kja-24311f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bad8/11637588/803876de8017/kja-24311f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bad8/11637588/48d259c913d9/kja-24311f2.jpg

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