Department of Anesthesiology, Xinqiao Hospital of Chongqing, Second Affiliated Hospital of Army Medical University, PLA, Chongqing, 400037, China.
Trials. 2024 Aug 27;25(1):565. doi: 10.1186/s13063-024-08417-x.
Delirium, marked by acute cognitive decline, poses a life-threatening issue among older individuals, especially after cardiac surgery, with prevalence ranging from 15 to 80%. Postoperative delirium is linked to increased morbidity and mortality. Although clinical trials suggest preventability, there is limited research on intranasal insulin (INI) for cardiac surgery-related delirium. INI has shown promise in managing cognitive disorders. It rapidly elevates brain hormone levels, enhancing memory even in non-impaired individuals. While effective in preventing delirium in gastrointestinal surgery, its impact after cardiac surgery remains understudied, especially for middle-aged patients.
This is a prospective randomized, double-blind, single-center controlled trial. A total of 76 eligible participants scheduled for elective on-pump cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either receive Intranasally administered insulin (INI) or intranasally administered normal saline. The primary outcome of our study is the incidence of postoperative delirium (POD). Secondary outcomes include duration of ICU, postoperative hospital length of stay, all in-hospital mortality, the change in MMSE scores pre- and post-operation, and incidence of postoperative cognitive dysfunction at 1 month, 3 months, and 6 months after operation. Moreover, we will subjectively and objectively evaluate perioperative sleep quality to investigate the potential impact of nasal insulin on the development of delirium by influencing sleep regulation.
Our study will aim to assess the impact of intranasal administration of insulin on the incidence of postoperative delirium in middle-aged patients undergoing on-pump elective cardiac surgery. If intranasal insulin proves to be more effective, it may be considered as a viable alternative for preventing postoperative delirium.
ChiCTR ChiCTR2400081444. Registered on March 1, 2024.
谵妄是一种以急性认知能力下降为特征的病症，在老年人中，尤其是在心脏手术后，具有很高的发病率，从 15%到 80%不等。术后谵妄与发病率和死亡率的增加有关。虽然临床试验表明可以预防，但对于心脏手术相关谵妄的鼻内胰岛素（INI）研究有限。INI 在治疗认知障碍方面显示出了希望。它可以迅速提高大脑激素水平，甚至在没有受损的个体中也能增强记忆力。虽然在胃肠道手术中预防谵妄有效，但在心脏手术后的效果仍有待研究，特别是对于中年患者。
这是一项前瞻性、随机、双盲、单中心对照试验。共纳入 76 名符合条件的择期体外循环心脏手术患者，按照 1:1 的比例随机分为接受鼻内胰岛素（INI）或鼻内生理盐水治疗组。我们研究的主要结局是术后谵妄（POD）的发生率。次要结局包括 ICU 持续时间、术后住院时间、全因死亡率、术前和术后 MMSE 评分的变化，以及术后 1 个月、3 个月和 6 个月的术后认知功能障碍发生率。此外，我们将主观和客观地评估围手术期睡眠质量，以研究鼻内胰岛素通过影响睡眠调节对谵妄发展的潜在影响。
我们的研究旨在评估鼻内给予胰岛素对接受体外循环择期心脏手术的中年患者术后谵妄发生率的影响。如果鼻内胰岛素被证明更有效，它可能被认为是预防术后谵妄的一种可行替代方法。
ChiCTR ChiCTR2400081444. 于 2024 年 3 月 1 日注册。
