在接受全关节置换手术的患者中使用外科手术期间的甲福明:随机对照的安慰剂试验研究的协议
Aidan Morrell1, Steven Shelofsky2, Hannah Hoffman2
1Orthopaedics, Oregon Health & Science University, Portland, Oregon, USA aidantmorrell@gmail.com.
BMJ open
|April 9, 2025
概括
本试点研究评估了一项临床试验的可行性,该试验使用外科手术期间的甲福尔来改善在全关节整形术患者的血糖控制. 梅特福林的使用可能会改善患者的治疗结果,并减少手术后的并发症.
科学领域:
- 整形外科手术 整形外科手术
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 在全关节整形术 (TJA) 中,术前血糖控制不良会增加并发症,死亡率和成本的风险.
- 在TJA后最佳的外科手术期间葡萄糖管理策略仍在争论中.
- 本研究评估了一项多中心随机对照试验 (RCT) 的可行性,该试验旨在研究TJA的外科手术期甲福明.
研究的目的:
- 评估在TJA中对外科手术期间的甲福明进行多中心RCT的可行性.
- 为了研究甲胺对TJA患者外科手术期间血糖控制的影响.
- 为TJA建立最佳的葡萄糖管理协议.
主要方法:
- 试点随机对照试验 (RCT) 与40名参与者进行部或膝盖关节整形.
- 盲目的,安慰剂控制的设计,使用甲福尔或安慰剂进行手术前2周,手术当天和手术后2天.
- 主要可行性结果:招聘,药物管理,坚持,保留. 二次结果:血糖变化,胰岛素使用,停留时间,感染,死亡率,再接收率.
主要成果:
- 可行性结果 (招聘,药物管理,坚持,保留) 将决定试点研究的成功.
- 二次结局将提供关于甲福明对血糖控制和患者结局的影响的初步数据.
- 将使用治疗意向分析.
结论:
- 这项试点研究将为设计一个更大的关于TJA的外科手术期间甲福林的RCT提供信息.
- 这些发现将指导为TJA患者开发基于证据的葡萄糖管理策略.
- 成功的可行性将为改善患者护理和结果铺平道路.
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