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预防性输注去甲肾上腺素对椎体成形术中低血压预防效果的随机临床试验。

Effect of prophylactic infusion of norepinephrine on the prevention of hypotension during vertebroplasty: a randomized clinical trial.

机构信息

Department of Anesthesiology, Affiliated Hospital of Medical School, Nanjing Drum Tower Hospital, Nanjing University, Nanjing, 210008, China.

Department of Anesthesiology, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 210028, China.

出版信息

BMC Surg. 2024 Oct 26;24(1):333. doi: 10.1186/s12893-024-02640-8.

DOI:10.1186/s12893-024-02640-8
PMID:39462386
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11515096/
Abstract

BACKGROUND

Transient hypotension is a common occurrence during the implantation of bone cement. This placebo-controlled randomized clinical trial study investigated the effect of prophylactic infusion of norepinephrine on the incidence of hypotension in senior patients who underwent vertebroplasty.

METHODS

The trial recruited patients who were greater than or equal to 65 years of age, had an American Society of Anesthesiologist physical status classification of I to III, and underwent vertebroplasty from August 2020 to August 2021 at the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine in China. The patients were randomly grouped according to whether they received either a norepinephrine infusion of 0.05 µg/kg/min or an equivalent volume of saline 10 min before implantation of bone cement. Intraoperative hemodynamics were monitored continuously by the MostCare system at the following 7 time points: 10 min before implantation of bone cement and immediately, 30 s, 1, 3, 5, and 10 min after implantation of bone cement. We also recorded the number of hypotensive episodes and the total number of vasopressors after implantation of bone cement. Multivariable logistic regression was used to assess the risk factors associated with hypotension after implantation of bone cement.

RESULTS

A total of 63 patients were randomized to the control group (n = 31; median [IQR] age, 74 [69-79] years) and the norepinephrine group (n = 32; median [IQR] age, 75 [71-79] years). The incidence of hypotension in the norepinephrine group was significantly lower than that in the control group after implantation of bone cement (12.5% vs. 45.2%; relative risk [RR], 3.61 [95% CI, 1.13-15.07]; P = 0.005). Moreover, the median (IQR) number of hypotensive episodes (0 [0-0] vs. 0 [0-2]; P = 0.005) and the total number of vasopressors (0 [0-0] vs. 0 [0-1]; P = 0.004) in the norepinephrine group were significantly lower than those in the control group. Furthermore, compared with the baseline, the MAP significantly decreased at 1 min (P = 0.007) and 3 min (P < 0.001) after bone cement implantation in the control group. However, the MAP at 3 min in the norepinephrine group was significantly higher than that in the control group (P < 0.001). The incidence of complications was not different between the groups. In multivariable logistic regression, the FRAIL score (OR, 2.29; 95% CI, 1.21-4.31) was identified as a risk factor associated with hypotension.

CONCLUSION

Prophylactic infusion of norepinephrine before bone cement implantation can stabilize hemodynamics and reduce the incidence of hypotension after implantation of bone cement.

摘要

背景

在骨水泥植入过程中会出现短暂性低血压。本安慰剂对照随机临床试验研究了在接受椎体成形术的老年患者中预防性输注去甲肾上腺素对低血压发生率的影响。

方法

该试验招募了年龄大于或等于 65 岁、美国麻醉医师协会身体状况分级为 I 至 III 级、并于 2020 年 8 月至 2021 年 8 月在南京大学中西医结合附属医院接受椎体成形术的患者。患者根据是否接受去甲肾上腺素 0.05μg/kg/min 或等量生理盐水在骨水泥植入前 10 分钟随机分组。术中血流动力学通过 MostCare 系统连续监测以下 7 个时间点:骨水泥植入前 10 分钟和立即、30 秒、1、3、5 和 10 分钟后。我们还记录了骨水泥植入后的低血压发作次数和血管加压药的总用量。多变量逻辑回归用于评估与骨水泥植入后低血压相关的危险因素。

结果

共有 63 名患者被随机分配至对照组(n=31;中位[IQR]年龄,74[69-79]岁)和去甲肾上腺素组(n=32;中位[IQR]年龄,75[71-79]岁)。骨水泥植入后,去甲肾上腺素组的低血压发生率明显低于对照组(12.5% vs. 45.2%;相对风险[RR],3.61[95%CI,1.13-15.07];P=0.005)。此外,去甲肾上腺素组的低血压发作次数(0[0-0] vs. 0[0-2];P=0.005)和血管加压药总用量(0[0-0] vs. 0[0-1];P=0.004)中位数(IQR)均明显低于对照组。此外,与基线相比,对照组骨水泥植入后 1 分钟(P=0.007)和 3 分钟(P<0.001)时 MAP 明显下降。然而,去甲肾上腺素组 3 分钟时的 MAP 明显高于对照组(P<0.001)。两组的并发症发生率无差异。多变量逻辑回归显示,衰弱评分(OR,2.29;95%CI,1.21-4.31)是与低血压相关的危险因素。

结论

骨水泥植入前预防性输注去甲肾上腺素可稳定血流动力学,降低骨水泥植入后低血压的发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/a1652cd25df1/12893_2024_2640_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/60795ac3cd6b/12893_2024_2640_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/644961675009/12893_2024_2640_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/a1652cd25df1/12893_2024_2640_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/60795ac3cd6b/12893_2024_2640_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/644961675009/12893_2024_2640_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f261/11515096/a1652cd25df1/12893_2024_2640_Fig3_HTML.jpg

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