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依托咪酯与地佐辛复合依托咪酯用于无痛胃镜麻醉的临床观察

The effectiveness of esketamine and propofol versus dezocine and propofol sedation during gastroscopy: A randomized controlled study.

机构信息

Department of Anesthesiology, Shunde Hospital of Southern Medical University, Foshan, China.

Department of Anesthesiology, The Affiliated Shunde Hospital of Jinan University, Foshan, China.

出版信息

J Clin Pharm Ther. 2022 Sep;47(9):1402-1408. doi: 10.1111/jcpt.13678. Epub 2022 Apr 30.

DOI:10.1111/jcpt.13678
PMID:35488787
Abstract

WHAT IS KNOWN AND OBJECTIVE

Propofol is widely used in painless gastroscopy. However, sedation with propofol alone might increase the risk of respiratory and circulatory complications. This randomized clinical study compares the efficacy and safety of esketamine or dezocine combined with intravenous (IV) propofol in patients undergoing gastroscopy.

METHODS

A total of 102 patients were enrolled in this study and randomized into two groups. All patients were adults aged 18-64 years who underwent upper gastrointestinal gastroscopy. Patients were randomly assigned to two groups to receive esketamine (0.3 mg/kg) combined with propofol (group E) or dezocine (0.05 mg/kg) combined with propofol (group D). In both groups, the drugs were administered intravenously. The primary outcome was the dose of propofol which provided a satisfactory sedative effect, both to the endoscopist and the patients. Secondary outcomes included recovery time, side effects (such as hypotension, nausea and vomiting and agitation), and the number of adverse circulatory and respiratory events.

RESULTS

Data of 83 patients were analysed in the present study. Dosage of propofol required in group E (1.44 mg/kg ± 0.67 mg/kg) was significantly lower compared with that in group D (2.12 mg/kg ± 0.37 mg/kg) (p < 0.0001). There was no statistically significant difference in recovery time, side effects, and the frequency of sedation-related adverse events between the two groups.

WHAT IS NEW AND CONCLUSION

The study indicates that intravenous injection of propofol and esmketamine is more effective for gastroscopy. Use of esketamine reduces the total amount of propofol required in ASA I-II patients undergoing gastroscopy compared with single use of dezocine. It also provides more stable hemodynamics, without affecting the recovery time and side effects such as respiratory and circulatory adverse events.

TRIAL REGISTRATION

The study was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number: ChiCTR2100051814) on 05/10/2021.

摘要

已知和目的

丙泊酚广泛用于无痛胃镜检查。然而,单独使用丙泊酚镇静可能会增加呼吸和循环并发症的风险。本随机临床研究比较了依托咪酯或地佐辛联合静脉(IV)丙泊酚在接受胃镜检查的患者中的疗效和安全性。

方法

本研究共纳入 102 例患者,随机分为两组。所有患者均为年龄在 18-64 岁之间接受上消化道胃镜检查的成年人。患者被随机分配到两组,分别接受依托咪酯(0.3mg/kg)联合丙泊酚(E 组)或地佐辛(0.05mg/kg)联合丙泊酚(D 组)。两组患者均静脉给药。主要结局是提供满意镇静效果的丙泊酚剂量,既满足内镜医师的要求,也满足患者的要求。次要结局包括恢复时间、副作用(如低血压、恶心呕吐和激越)以及不良循环和呼吸事件的发生次数。

结果

本研究分析了 83 例患者的数据。E 组(1.44mg/kg±0.67mg/kg)所需丙泊酚剂量明显低于 D 组(2.12mg/kg±0.37mg/kg)(p<0.0001)。两组患者的恢复时间、副作用以及镇静相关不良事件的发生率无统计学差异。

新发现和结论

该研究表明,静脉注射丙泊酚和依托咪酯用于胃镜检查更有效。与单独使用地佐辛相比,在 ASA I-II 级患者中使用依托咪酯可减少胃镜检查所需的丙泊酚总量。它还提供更稳定的血液动力学,不影响恢复时间和呼吸循环等副作用不良事件的发生。

试验注册

本研究于 2021 年 10 月 5 日在中国临床试验注册中心(www.chictr.org.cn;注册号:ChiCTR2100051814)注册。

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