对乙酰氨基酚围术期给药对术后寒战的影响:随机、三盲、安慰剂对照试验

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Effects of Perioperative Administration of Acetaminophen on Postoperative Shivering: A Randomized, Triple-Blind,Placebo-Controlled Trial

背景与目的

在本随机、三盲、安慰剂对照的试验中,我们验证了对乙酰氨基酚(acetaminophen )围手术期给药对术后寒战有预防作用的假设。

方  法

45名妇科剖腹术的妇女被随机分配到对乙酰氨基酚或安慰剂组。全麻诱导后,静脉输注试验药物(对乙酰氨基酚15 mg/kg)或安慰剂(0.9%生理盐水)15分钟以上。病人麻醉后在麻醉复苏室停留30分钟,并且观察术后严重寒战的发生率(即寒战评分>2分)。对于继发结果,在麻醉诱导前(T0)、手术开始(T1)、手术结束(T2)、在麻醉复苏室(T3)开始术后观察,T3后30分钟(T4)分别记录额头核心体温(BT)。在T4后1小时(T5),从腋窝(BTA)记录BT。初步结果用χ2检验进行分析。分别使用双向重复测量方差分析(ANOVA)和2样本t检验分析从前额和腋窝记录的核心温度(BT)。在所有比较中,P值<0.05被认为具有统计学意义。

结 果  

研究持续2年。在最初登记的45名患者中,8名被排除在外。对乙酰氨基酚组和安慰剂组分别为18例和19例。对乙酰氨基酚组术后严重寒战的发生率(22.2%)明显低于安慰剂组(73.7%)(相对危险度,0.302;9),95%置信区间,0.122–0.746;p=0.005)。在BTF中,双向重复方差分析显示时间效应显著(F4,140=54.8;P<.001),处理交互作用时间显著(F4,140=9.61;P<.001),但未显示出主要效应。此外,对乙酰氨基酚组T5的腋窝核心温度(BTA)(平均[标准差{SD}],37.2℃[0.48℃])明显低于安慰剂组(37.9℃[0.63℃];P<.001)。

结 论

在妇科剖腹手术病人的研究表明,围手术期使用对乙酰氨基酚可以预防术后严重寒战。他的预防作用可能是由于抑制术后核心温度(BT)调定点增加,而不是像可乐定那样降低寒战的阈值。

原始文献摘要

Kinjo T, Tadokoro T, Tokushige A, Zamami T, Taira S, Ikehara Y, Tsuhako C,Ohtsu H, Ueda S, Kakinohana M. Effects of Perioperative Administration of Acetaminophen on Postoperative Shivering: A Randomized, Triple-Blind,Placebo-Controlled Trial. Anesth Analg. 2019 Jun 24. doi:10.1213/ANE. 0000000000004306. [Epub ahead of print] PubMed PMID: 31274602.

BACKGROUND: In this randomized, triple-blind, placebo-controlled trial, we tested the hypothesis that perioperative acetaminophen administration has a prophylactic effect on postoperative shivering.

METHODS: Forty-five women scheduled for gynecological laparotomy were randomized to either the acetaminophen or the placebo groups. After induction of general anesthesia, the test drug (acetaminophen 15 mg/kg) or placebo (0.9% saline) was intravenously administered over 15 minutes. The primary outcome measure was the incidence of severe postoperative shivering (ie, shivering score >2) in the postanesthesia care unit, where patients stayed for 30 minutes after their emergence from anesthesia. For the secondary outcomes, core body temperature (BT) was recorded at the forehead just before anesthesia induction (time 0 [T0]), at the start of surgery (time 1 [T1]), at the end of surgery (time 2 [T2]), at the initiation of postoperative observation in the postanesthesia care unit (time 3 [T3]), and 30 minutes after T3 (time 4 [T4]). At 1 hour after T4 (ie, time 5 [T5]), the BT was recorded from the axilla (BTA). Primary outcome was analyzed using a χ2 test. BT recorded at the forehead (BTF) and BTA were analyzed using a 2-way -repeated-measures analysis of variance (ANOVA) and a 2-sample t test, respectively. For all comparisons, a P value <.05 was considered statistically significant.

RESULTS: The study duration was 2 years. Of the 45 patients initially enrolled, 8 patients were excluded. The acetaminophen and placebo groups included 18 and 19 patients, respectively. The incidence of severe postoperative shivering in the postanesthesia care unit was significantly lower in the acetaminophen group (22.2%) than in the placebo group (73.7%) (relative risk, 0.302; 95% confidence interval, 0.122–0.746; P = .005). Two-way repeated-measures ANOVA showed a significant effect of time (F4,140 = 54.8; P < .001) and a significant time by treatment interaction (F4,140 = 9.61; P < .001) but did not show a main effect of the treatment (F1,35 = 1.83; P = .185) in BTF. Moreover, BTA at T5 was significantly lower in the acetaminophen group (mean [standard deviation {SD}], 37.2°C [0.48°C]) than in the placebo group (37.9°C [0.63°C]; P < .001).

CONCLUSIONS: Our findings in patients undergoing gynecological laparotomy suggest that perioperative acetaminophen administration can prevent postoperative severe shivering. This prophylactic effect might be due to suppressing the postoperative increase in the BT set point, rather than lowering the threshold for shivering, as observed with clonidine.

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翻译:任文鑫  编辑:何幼芹  审校:王贵龙

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