无阿片麻醉联合髂筋膜神经阻滞对接受髋部骨折手术的老年患者围手术期神经认知障碍的影响:一项前瞻性、多中心、平行组、随机对照试验的研究方案。

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-04-05 DOI:10.1186/s13063-025-08828-4
Tong Zhi, Shirong Wei, Jiao Kuang, Sitong Zhou, Danhong Yu, Tesheng Gao, Long Lei, Chengfei Xu, Liang Cheng, Qinghe Zhou, Ming Yao, Huadong Ni
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引用次数: 0

摘要

背景:围手术期神经认知功能障碍(PND)是影响老年手术患者的一种普遍并发症,对术后康复和长期功能独立构成了巨大挑战。尽管人们越来越意识到其临床意义,但目前有关有效神经保护麻醉策略的证据仍不确定。新出现的证据表明,不含阿片类药物的麻醉(OFA)策略既能维持镇痛效果,又能减轻与阿片类药物相关的神经炎症机制,而这正是 PND 的发病机制。这项多中心试验研究了髂筋膜神经阻滞与超声引导髂筋膜神经阻滞相结合,对减轻接受髋部骨折手术的老年患者 PND 的疗效:这项多中心随机对照试验将招募 348 名患者,随机分配他们接受 OFA 联合髂筋膜神经阻滞或阿片类药物麻醉 (OBA) 联合髂筋膜神经阻滞。所有患者都将在气管插管的全身麻醉下接受髋部骨折手术。主要结果是综合神经认知评分的变化,通过神经心理学测试评估从基线到术后 3 个月的变化。次要结果包括血清蛋白和炎症标志物的变化、拔管时间、术后疼痛发生率、术中血流动力学稳定性和术后恢复参数。此外,还将评估 OFA 在髋关节手术中的安全性:讨论:有效预防 PND 对于优化老年患者的术后恢复和长期功能预后至关重要。本试验旨在完善和优化麻醉管理策略,以降低PND的发生率,改善术后生活质量,最终提高围术期神经认知结果:本试验方案已于 2023 年 12 月 14 日在中国临床试验注册中心注册,注册号为:ChiCTR2300078647:ChiCTR2300078647。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effects of opioid-free anesthesia combined with iliofascial nerve block on perioperative neurocognitive deficits in elderly patients undergoing hip fracture surgery: study protocol for a prospective, multicenter, parallel-group, randomized controlled trial.

Background: Perioperative neurocognitive dysfunction (PND), a prevalent complication affecting elderly surgical patients, poses substantial challenges to postoperative rehabilitation and long-term functional independence. Despite growing awareness of its clinical significance, current evidence regarding effective neuroprotective anesthetic strategies remains inconclusive. Where emerging evidence suggests opioid-free anesthesia (OFA) strategies could maintain analgesic efficacy while potentially attenuating opioid-associated neuroinflammatory mechanisms implicated in PND pathogenesis. This multicenter trial investigates the efficacy of OFA combined with ultrasound-guided iliofascial nerve block in mitigating PND among geriatric patients undergoing hip fracture surgery.

Methods: This multicenter, randomized controlled trial will enroll 348 patients, who will be randomly assigned to receive either OFA combined with iliofascial nerve block or opioid-based anesthesia (OBA) combined with iliofascial nerve block. All patients will undergo hip fracture surgery under general anesthesia with tracheal intubation. The primary outcome will be the change in composite neurocognitive scores, assessed through a battery of neuropsychological tests from baseline to 3 months postoperatively. Secondary outcomes include alterations in serum protein and inflammatory markers, extubation time, postoperative pain incidence, intraoperative hemodynamic stability, and postoperative recovery parameters. The safety profile of OFA in hip surgery will also be assessed.

Discussion: Effective prevention of PND is crucial for optimizing postoperative recovery and long-term functional outcomes in elderly patients. This trial aims to refine and optimize anesthesia management strategies to reduce the incidence of PND, improve postoperative quality of life, and ultimately enhance perioperative neurocognitive outcomes.

Trial registration: This trial protocol was registered with the China Clinical Trial Registry on December 14, 2023, under the registration number: ChiCTR2300078647.

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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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