Efficacy and Safety of Remimazolam Tosilate Combined with Propofol in Digestive Endoscopy: A Randomised Trial

IF 2.1 4区医学 Q3 PHARMACOLOGY & PHARMACY

Journal of Clinical Pharmacy and Therapeutics Pub Date : 2023-04-25 DOI:10.1155/2023/9955312

Liting Cui, Kun Shu, Panpan Zhang, Qihao Cui, Huifang Yun

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引用次数: 0

Abstract

Current Knowledge and Objective. Remimazolam tosilate is a novel intravenous sedative of benzodiazepines with no tissue accumulation, which offers a faster onset of action and recovery time than midazolam. The aim of this trial was to compare the efficacy and safety of remimazolam (RM) combined with propofol and traditional propofol in painless digestive endoscopy with painless gastroscopy and colonoscopy. Methods. Patients were randomised into three groups: RM combined with propofol (RMP group, n = 35), RM (RM group, n = 40), and propofol (P group, n = 38). Each group received 0.1 μg/kg sufentanyl analgesia. An induction dose of 0.1 mg/kg RM and 1 mg/kg propofol was administered to the RMP group, 0.3 mg/kg RM to the RM group, and 2 mg/kg propofol to the P group. Per 5 min, the RMP and RM groups received an additional dose of 0.05 mg/kg RM, while the P group received an extra 0.5 mg/kg propofol. The comparisons involved induction regimen success rate, incidence of hypotension, low pulse rate, injection pain, grade of low oxygen saturation (SpO2), and postoperative adverse reactions. Results and Discussion. The RMP and P groups’ composition powers were 100%, and the RM group’s composition power was 95% ( P = 0.113 ). The incidence rates of hypotension were 40.0%, 18.4%, and 44.7% in the RMP, RM, and P groups, respectively ( P = 0.037 ). The low pulse incidence rates were 5.7%, 2.6%, and 5.3% in the RMP, RM, and P groups, respectively ( P = 0.771 ). The incidence rates of injection pain were 11.4%, 2.6%, and 26.3% in the RMP, RM, and P groups, respectively ( P = 0.007 ). There was no significant difference in low SpO2 severity scores ( P = 0.148 ). New Findings and Conclusion. Remimazolam tosilate combined with propofol can be used for painless endoscopy, with almost the same safety as propofol. Remimazolam tosilate produces a low incidence of adverse reactions and is a safe anaesthetic option for painless endoscopies.

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Tosilate Remimazolam联合丙泊酚在消化内镜检查中的疗效和安全性：一项随机试验

目前的知识和目标。托silate Remimazolam是一种新型的苯二氮卓类静脉镇静剂，没有组织积累，比咪达唑仑起效和恢复时间更快。本试验的目的是比较雷马唑仑(RM)联合异丙酚和传统异丙酚在无痛消化内镜、无痛胃镜和结肠镜检查中的疗效和安全性。方法。将患者随机分为三组:RM联合异丙酚组(RMP组，n = 35)、RM组(RM组，n = 40)和丙泊酚组(P组，n = 38)。各组均给予0.1 μg/kg舒芬太尼镇痛。RMP组诱导剂量为0.1 mg/kg RM和1 mg/kg异丙酚，RM组诱导剂量为0.3 mg/kg RM, P组诱导剂量为2 mg/kg异丙酚。每5 min, RMP组和RM组额外给药0.05 mg/kg RM, P组额外给药0.5 mg/kg异丙酚。比较诱导方案的成功率、低血压发生率、低脉率、注射疼痛、低氧饱和度(SpO2)等级和术后不良反应。结果和讨论。RMP组和P组的组成率为100%，RM组的组成率为95% (P = 0.113)。RMP组、RM组、P组低血压发生率分别为40.0%、18.4%、44.7% (P = 0.037)。RMP组、RM组和P组低脉冲发生率分别为5.7%、2.6%和5.3% (P = 0.771)。RMP组、RM组、P组注射痛发生率分别为11.4%、2.6%、26.3% (P = 0.007)。低SpO2严重程度评分差异无统计学意义(P = 0.148)。新发现和结论。雷马唑仑联合异丙酚可用于无痛内窥镜检查，其安全性与异丙酚几乎相同。雷马唑仑不良反应发生率低，是无痛内窥镜检查的安全麻醉选择。

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来源期刊

Journal of Clinical Pharmacy and Therapeutics 医学-药学

CiteScore

4.10

自引率

5.00%

发文量

226

审稿时长

6 months

期刊介绍： The Journal of Clinical Pharmacy and Therapeutics provides a forum for clinicians, pharmacists and pharmacologists to explore and report on issues of common interest. Reports and commentaries on current issues in medical and pharmaceutical practice are encouraged. Papers on evidence-based clinical practice and multidisciplinary collaborative work are particularly welcome. Regular sections in the journal include: editorials, commentaries, reviews (including systematic overviews and meta-analyses), original research and reports, and book reviews. Its scope embraces all aspects of clinical drug development and therapeutics, including: Rational therapeutics Evidence-based practice Safety, cost-effectiveness and clinical efficacy of drugs Drug interactions Clinical impact of drug formulations Pharmacogenetics Personalised, stratified and translational medicine Clinical pharmacokinetics.