老年患者全膝关节置换术中的术中虚拟现实：一项随机临床试验的研究方案
Intraoperative virtual reality for older patients undergoing total knee arthroplasty: study protocol for a randomized clinical trial.
作者信息
Espinosa-Leon Juan P, Mathura Ryan, Chen Guanqing, Joseph Melisa, Sadhwani Trishna, Beydoun Najla, Hernandez Edjay R, Riley Tyler, Kunze Lisa J, Goodspeed Valerie, O'Gara Brian P
机构信息
Department of Anesthesia, Critical Care, and Pain Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, USA.
University of North Dakota School of Medicine and Health Sciences, 1301 N Columbia Road, Grand Forks, ND, USA.
出版信息
Trials. 2024 Dec 18;25(1):830. doi: 10.1186/s13063-024-08551-6.
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 min). 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.
背景
在老年外科患者群体中，预防诸如过度镇静等并发症在围手术期护理中已变得愈发重要。术中使用虚拟现实（VR）可能会降低镇静药物的需求量。我们假设，与主动对照和常规护理对照相比，在全膝关节置换术（TKA）期间使用沉浸式VR将导致丙泊酚需求量减少、患者报告的满意度提高以及术后阿片类药物需求量降低。
方法
这是一项针对接受TKA的老年（年龄>60岁）患者的单中心随机临床试验。参与者将被随机分为三组（2:2:1）：VR沉浸式组、音乐组和假VR加常规护理组。所有患者都将接受区域阻滞和脊髓麻醉。沉浸式VR组和音乐组的患者将使用丙泊酚进行患者自控镇静（PCS），而假VR组的患者将作为护理对照组的标准，接受丙泊酚输注的监护麻醉护理（MAC）。
统计分析
将使用IBM SPSS Statistics 25版本进行分析，将双侧p值<0.05视为具有统计学意义。主要结局是丙泊酚的术中剂量（mg·kg·min）。次要结局包括患者满意度、麻醉后护理单元（PACU）住院时间、术后疼痛评分和镇痛药物需求量、功能结局、术后谵妄和术后神经认知。
讨论
在TKA期间，VR作为区域阻滞和脊髓麻醉的非药物辅助手段，可能会降低镇静药物需求量，同时保持患者满意度。如果属实，这种尽量减少镇静的方法可能会影响临床结局，包括老年患者的围手术期并发症和住院时间，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。
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