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【罂粟摘要】苯磺酸瑞马唑仑与丙泊酚对心脏手术患者术后妄想发生率的影响:一项随机对照试验的研究方案

 罂粟花anesthGH 2021-12-26

苯磺酸瑞马唑仑与丙泊酚对心脏手术患者术后妄想发生率的影响:一项随机对照试验的研究方案




贵州医科大学 麻醉与心脏电生理课题组

翻译:吴学艳 编辑:潘志军 审校:曹莹

 背景

谵妄是一种急性认知功能障碍,表现为认知波动、冷漠和无组织思维,导致发病率、死亡率、重症监护病房(ICU)住院时长及总医疗费用增加。在行心脏手术患者中,谵妄也增加了术后并发症的风险,如呼吸功能不全、胸骨不易固定及需再次行胸骨固定手术;本研究旨在评估患者行心脏手术后使用苯磺酸瑞马唑仑、丙泊酚镇静对术后谵妄发生率的影响。

 方法

在这项前瞻性、双盲、随机对照临床试验中,招募2021年1月1日至2021年12月31日期间接受心脏手术的200名患者,术后随机接受苯磺酸瑞马唑仑或丙泊酚输注镇静,直至拔管。主要观察指标为术后5天内谵妄发生率;次要观察指标包括谵妄发作时间、谵妄持续时长、ICU住院时长、总住院时长和机械通气时长。

 讨论

本研究主要目的是评估与丙泊酚镇静相比,苯磺酸瑞马唑仑是否能降低心脏手术患者术后谵妄的发生率。在此项初步随机对照临床试验中,我们将检验这一假设:在心脏手术患者中,与丙泊酚镇静相比,使用苯磺酸瑞马唑仑降低了心脏手术患者术后谵妄的发生率。




原始文献来源 ☟

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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