【罂粟摘要】瑞马唑仑预处理预防丙泊酚在人工流产或清宫术患者中注射痛的镇痛效果：一项前瞻性、双盲、随机、安慰剂对照临床试验

瑞马唑仑预处理预防丙泊酚在人工流产或清宫术患者中注射痛的镇痛效果：一项前瞻性、双盲、随机、安慰剂对照临床试验

贵州医科大学  麻醉与心脏电生理课题组

翻译：吴学艳  编辑：张中伟  审校：曹莹

背景  

丙泊酚诱导注射痛(PIP)是全麻中一个众所周知的问题，我们假设瑞马唑仑预处理可以预防人工流产或清宫患者的PIP。

材料和方法  

在这项前瞻性、单中心、双盲、随机、安慰剂对照的临床试验中，18-60岁接受人流或清宫手术的成年患者随机分为三组；利多组给予利多卡因(0.5 mg/kg,iv)，瑞马唑仑组接受瑞马唑仑(0.1mg/kg,iv)，生理盐水（NS）组接受相同体积的0.9%NS。在注射利多卡因、瑞马唑仑或生理盐水60s后，以12ml/分的速度注射丙泊酚，直至意识消失。主要观察指标为采用4分制评分评估丙泊酚注射时PIP的发生率；次要观察指标包括丙泊酚注射疼痛、生命体征、麻醉和手术特征以及不良事件。

结果  

NS组PIP发生率明显高于利多卡因组和瑞马唑仑组(分别为75.7%、44.3%和42.9%，P<0.001)；中度PIP发生率NS组明显高于利多卡因组和瑞马唑仑组(分别为20.0%、2.90%和1.4%，P<0.001)。瑞马唑仑组丙泊酚用量、低氧血症、需要托下颌等不良事件发生率均低于NS组和利多卡因组；此外，体动反应和呛咳发生率明显低于NS组和利多卡因组。NS组恢复时间明显长于利多卡因组和瑞马唑仑组。

结论  

瑞马唑仑预处理可降低人工流产或清宫患者PIP的发生率和强度，与利多卡因相当，且无严重不良反应。

原始文献来源  

Guan X, Jiao Z, Gong X, et al.Efficacy of Pre-Treatment with Remimazolam on Prevention of Propofol-Induced Injection Pain in Patients Undergoing Abortion or Curettage: A Prospective,Double-Blinded, Randomized and Placebo-Controlled Clinical Trial.[J]. Drug Des Devel Ther. 2021 Nov 4;15:4551 -4558. DOI: 10.2147/DDDT.S334100.

Efficacy of Pre-Treatment with Remimazolam on Prevention of Propofol - Induced Injection Pain in Patients Undergoing Abortion or Curettage: A Prospective, Double-Blinded, Randomized and Placebo-Controlled Clinical Trial

Abstract

Background: Propofol-induced injection pain (PIP) is a well-known problem in general anesthesia. We hypothesized that pre-treatment with remimazolam prevents PIP in patients undergoing abortion or curettage.

Materials and methods: In this prospective, single-center, double-blinded, randomized, placebo-controlled clinical trial, adult patients aged 18 to 60 undergoing abortion or curettage were randomly assigned to three groups. Group Lido received system lidocaine (a bolus of 0.5 mg kg-1, iv). Group Remi received remimazolam (a bolus of 0.1 mg kg-1, iv). Group NS received identical volumes of 0.9% normal saline. Sixty seconds after the injection of lidocaine, remimazolam or saline, patients were injected with propofol at a rate of 12 mL/min until the loss of consciousness. The primary outcome was the incidence of PIP at the time of induction using 4-point scale. Secondary outcomes included propofol-induced injection pain, vital signs, the characteristics of anesthesia and surgery, and adverse events.

Results: The incidence of patients with PIP was higher in group NS than that in group Lido and group Remi (75.7, 44.3, and 42.9%, respectively, p < 0.001). The percentages of patients with moderate PIP were higher in group NS than that in group Lido and group Remi (20.0, 2.9, and 1.4%, respectively, p < 0.001). Moreover, the consumption of propofol and the incidence of adverse event (hypoxemia and chin lifting) in group Remi were lower than that in group NS and Lido, and less patients got physical movement and cough in group Remi. The recovery time in group NS was longer than that in group Lido and Remi.

Conclusion: Our findings indicate that pre-treatment with remimazolam reduced the incidence and intensity of PIP in abortion or curettage patients, equivalent to that of lidocaine without severe adverse effects.

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