皮用于预防消化器外科手术 (HyPOD) 中的术后痴呆症:多中心随机,盲目,安慰剂控制试验的研究方案
Tsukasa Aritake1,2, Yukihiro Yokoyama2, Masahiko Ando3
1Department of Surgery, National Center for Geriatrics and Gerontology, Obu, Japan ari1736ten@gmail.com.
BMJ open
|July 31, 2025
概括
这项研究调查了皮 (HC) 是否可以预防消化器外科手术患者的手术后狂妄症 (POD). 结果将澄清HC在减少这种常见并发症和改善患者结果方面的作用.
科学领域:
- 麻醉学和外科手术期间的医学.
- 手术重症监护手术重症监护
- 药理学 药理学是指药理学的学科.
背景情况:
- 手术后妄 (POD) 是消化器外科手术中常见的并发症,与住院时间,费用和死亡率的增加有关.
- 虽然其他皮质类固醇,如甲显示承诺,皮质 (HC) 预防POD的疗效尚未确立.
- 了解HC的潜在作用对于优化消化器外科手术后的患者护理至关重要.
研究的目的:
- 评估皮 (HC) 在接受消化器外科手术的患者中预防术后妄想症 (POD) 的有效性.
- 为了在随机,盲目的和受控试验环境中比较HC管理与安慰剂.
- 收集关于HC对关键次要结果的影响的数据,包括死亡率和住院时间.
主要方法:
- 一个多中心,随机,双盲,安慰剂对照试验,涉及接受消化器外科手术的患者.
- 参与者被随机分配,在皮肤切割之前接受500毫克静脉注射的皮或盐水安慰剂.
- 主要结果是用混评估方法-ICU (CAM-ICU) 从术后1至3天评估的POD发病率.
主要成果:
- 该研究正在进行中,截至最新更新,计划180名患者中有61名患者被录取.
- 目前正在收集初级和二级结局数据,以评估皮的有效性和安全性,以预防POD.
- 分析将重点关注POD的发病率和相关的临床结果.
结论:
- 该试验正在积极招募人才,以确定皮能否有效地预防消化器外科手术患者的术后狂妄症.
- 预计这些发现将为临床实践提供有关用于POD预防的皮质类固醇使用的信息.
- 计划通过同行评审的出版物传播结果.
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