Intraoperative virtual reality for older patients undergoing total knee arthroplasty: study protocol for a randomized clinical trial.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-12-18 DOI:10.1186/s13063-024-08551-6

Juan P Espinosa-Leon, Ryan Mathura, Guanqing Chen, Melisa Joseph, Trishna Sadhwani, Najla Beydoun, Edjay R Hernandez, Tyler Riley, Lisa J Kunze, Valerie Goodspeed, Brian P O'Gara

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Abstract

Background: In an aging surgical patient population, preventing complications such as oversedation has taken increasing priority in perioperative care. Intraoperative use of virtual reality (VR) may decrease sedative requirements. We hypothesize that the use of immersive VR during total knee arthroplasty (TKA) will lead to decreased propofol requirements, improved patient-reported satisfaction, and reduced postoperative opioid requirements compared to active and usual care controls.

Methods: This is a single-center, randomized clinical trial of older (age > 60) patients undergoing TKA. Participants will be randomized into three groups (2:2:1): VR immersion, music, and sham VR plus usual care. All patients will receive a regional block and spinal anesthesia. Patients in the immersive VR and music groups will use patient-controlled sedation (PCS) with propofol, while those in the sham VR group will act as the standard of care control group and will receive monitored anesthesia care (MAC) with propofol infusion.

Statistical analysis: Analyses will be conducted using IBM SPSS Statistics Version 25, considering a two-sided p-value < 0.05 to be statistically significant. The primary outcome is the intraoperative dose of propofol (mg kg^-1 min^-1). Secondary outcomes include patient satisfaction, post-anesthesia care unit (PACU) length of stay, postoperative pain scores and analgesic requirements, functional outcomes, postoperative delirium, and postoperative neurocognition.

Discussion: VR used as a non-pharmacological adjunct to regional and spinal anesthesia during TKA may reduce sedative requirements while maintaining patient satisfaction. If true, this approach to minimizing sedation may impact clinical outcomes including perioperative complications and length of stay for older patients, while maintaining a high degree of patient satisfaction.

Trial registration: This trial was registered on ClinicalTrials.gov on January 29, 2021. The registration number is NCT04748549.

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老年全膝关节置换术患者术中虚拟现实：随机临床试验的研究方案。

背景：在老年外科患者群体中，预防并发症如过度镇静已成为围手术期护理的重中之重。术中使用虚拟现实（VR）可减少镇静需求。我们假设在全膝关节置换术（TKA）中使用沉浸式VR将减少丙泊酚的需求，提高患者报告的满意度，并减少术后阿片类药物的需求，与主动和常规护理对照相比。方法：这是一项单中心、随机临床试验，研究对象是年龄在60 ~ 60岁之间的老年TKA患者。参与者将被随机分为三组（2:2:1）：VR沉浸、音乐和假VR加常规护理。所有病人都将接受局部阻滞和脊髓麻醉。沉浸式VR组和音乐组采用丙泊酚患者控制镇静（PCS），假VR组作为标准护理对照组，采用丙泊酚输注麻醉监护（MAC）。统计分析：将使用IBM SPSS Statistics Version 25进行分析，考虑双面p值（-1 min-1）。次要结局包括患者满意度、麻醉后护理单位（PACU）住院时间、术后疼痛评分和镇痛需求、功能结局、术后谵妄和术后神经认知。讨论：在TKA期间，VR作为区域麻醉和脊髓麻醉的非药物辅助可以减少镇静需求，同时保持患者满意度。如果是这样，这种最小化镇静的方法可能会影响临床结果，包括围手术期并发症和老年患者的住院时间，同时保持高度的患者满意度。试验注册：该试验于2021年1月29日在ClinicalTrials.gov上注册。注册号为NCT04748549。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.