苯磺酸瑞馬唑侖與丙泊酚對(duì)心臟手術(shù)患者術(shù)后妄想發(fā)生率的影響：一項(xiàng)隨機(jī)對(duì)照試驗(yàn)的研究方案

貴州醫(yī)科大學(xué) 麻醉與心臟電生理課題組

翻譯：吳學(xué)艷 編輯：潘志軍 審校：曹瑩

 背景

譫妄是一種急性認(rèn)知功能障礙，表現(xiàn)為認(rèn)知波動(dòng)、冷漠和無(wú)組織思維，導(dǎo)致發(fā)病率、死亡率、重癥監(jiān)護(hù)病房(ICU)住院時(shí)長(zhǎng)及總醫(yī)療費(fèi)用增加。在行心臟手術(shù)患者中，譫妄也增加了術(shù)后并發(fā)癥的風(fēng)險(xiǎn)，如呼吸功能不全、胸骨不易固定及需再次行胸骨固定手術(shù)；本研究旨在評(píng)估患者行心臟手術(shù)后使用苯磺酸瑞馬唑侖、丙泊酚鎮(zhèn)靜對(duì)術(shù)后譫妄發(fā)生率的影響。

 方法

在這項(xiàng)前瞻性、雙盲、隨機(jī)對(duì)照臨床試驗(yàn)中，招募2021年1月1日至2021年12月31日期間接受心臟手術(shù)的200名患者，術(shù)后隨機(jī)接受苯磺酸瑞馬唑侖或丙泊酚輸注鎮(zhèn)靜，直至拔管。主要觀察指標(biāo)為術(shù)后5天內(nèi)譫妄發(fā)生率；次要觀察指標(biāo)包括譫妄發(fā)作時(shí)間、譫妄持續(xù)時(shí)長(zhǎng)、ICU住院時(shí)長(zhǎng)、總住院時(shí)長(zhǎng)和機(jī)械通氣時(shí)長(zhǎng)。

 討論

本研究主要目的是評(píng)估與丙泊酚鎮(zhèn)靜相比，苯磺酸瑞馬唑侖是否能降低心臟手術(shù)患者術(shù)后譫妄的發(fā)生率。在此項(xiàng)初步隨機(jī)對(duì)照臨床試驗(yàn)中，我們將檢驗(yàn)這一假設(shè):在心臟手術(shù)患者中，與丙泊酚鎮(zhèn)靜相比，使用苯磺酸瑞馬唑侖降低了心臟手術(shù)患者術(shù)后譫妄的發(fā)生率。

原始文獻(xiàn)來(lái)源 ?

Yang M, Liu X, Yang D,et al. Effect of remimazolam besylate compared with propofol on the incidence of delirium after cardiac surgery: study protocol for a randomized trial.[J]. Trials. 2021 Oct 18;22(1):717. DOI: 10.1186/s1 3063-021-05691-x. 

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英文原文

Effect of remimazolam besylate compared with propofol on the incidence of delirium after cardiac surgery: study protocol for a randomized trial

Abstract

Background: Delirium is an acute cognitive disorder that presents with fluctuation in cognition, apathy, and non-organized thinking, resulting in increased morbidity, mortality, intensive care unit (ICU) stay, and total healthcare costs. In patients undergoing cardiac surgery, delirium also increases the risk of postoperative complications, such as respiratory insufficiency, sternum instability, and need for re-operation of the sternum. This study aims to understand the incidence of delirium in patients after cardiac surgery in patients sedated with remimazolam besylate versus propofol.

Methods: In this prospective, double-blind, randomized controlled clinical trial, we aim to recruit 200 patients undergoing cardiac surgery between January 1, 2021, and December 31, 2021, who will be randomized to receive either remimazolam besylate or propofol infusions postoperatively, until they are extubated. The primary outcome is the incidence of delirium within 5 days after surgery. Secondary outcomes include the time of delirium onset, duration of delirium, ICU length of stay, hospital length of stay, and mechanical ventilation time.

Discussion: The key objective of this study is to assess whether remimazolam besylate reduces the incidence of delirium in patients after cardiac surgery compared to propofol sedation. In this preliminary randomized controlled clinical trial, we will test the hypothesis that the use of remimazolam besylate lowers the incidence of delirium when compared to propofol in patients undergoing cardiac surgery.

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