背景：麻醉和手术等伤害性刺激对老年全髋关节置换术中应激反应和血流变指标的影响较为明显，容易使患者自身的生理机能受干扰，置换后免疫功能下降，影响置换后的髋关节功能恢复。以往老年患者行髋关节置换的麻醉方式主要为全身麻醉，腰椎穿刺麻醉及硬膜外麻醉等单一麻醉方法。以往有研究表明，老年全髋关节置换患者更适合采用联合神经阻滞麻醉，更安全可靠。目的：观察联合神经阻滞麻醉对老年全髋关节置换术中应激及置换后免疫功能的影响。方法：研究为前瞻性、单中心、随机对照、开放性临床试验，在中国青海，青海大学附属医院完成。将纳入试验的老年全髋关节置换患者120例随机分为2组，每组60例，试验组术中采取联合神经阻滞麻醉，包括下肢腰丛、坐骨神经、L1-2椎旁神经联合阻滞麻醉，对照组术中采用全身麻醉，随访3个月。试验的主要观察指标为术中患者血清皮质醇浓度评价术中应激反应情况；次要观察指标为麻醉前、术前，置换后即刻血清皮质醇浓度，以及麻醉前、术前，术中、置换后即刻血糖浓度评价患者各时间段的应激反应情况；免疫功能相关指标包括麻醉前，置换后即刻，置换后1，3，7 d及3个月患者白细胞、中性粒细胞绝对值、白细胞介素1，6、肿瘤坏死因子α、T淋巴细胞亚群水平，评价患者置换后的免疫功能；血流动力学指标包括麻醉前，术中，置换后即刻心电图，脉搏，收缩压、舒张压、心率、血气分析检测结果，观察患者血液相关参数的变化；置换后1，3，7 d及3个月不良事件发生率，以评价患者置换后的并发症发生情况。试验经中国青海大学附属医院医学伦理委员会批准(审批号：QHY1017D)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者对试验内容和治疗过程均知情同意，并签署知情同意书。讨论：试验比较联合神经阻滞麻醉及全麻对老年全髋关节置换患者术中应激及置换后免疫功能影响的差异，旨在为老年全髋关节置换术中多种麻醉方法的选择提供客观依据，从而有利于降低术中风险，减少置换后早期并发症的发生。试验注册信息：试验于2016年8月19日在北美临床试验注册中心注册(NCT02884388)。%BACKGROUND:Anesthesia, surgery, and other nociceptive stimuli affect stress and hemorheological indices, impact physiological function, decrease immune function, and thereby influence recovery of hip joint function in elderly patients who undergo total hip replacement. Previous anesthesia methods for hip replacement in elderly patients include general, lumbar puncture, or epidural anesthesia alone. A combined nerve block is more suitable for total hip replacement in the elderly because of the safety and reliability of the method. In this study, we hypothesized that a combined nerve block is superior to any previous anesthesia method alone for total hip replacement in the elderly. Specifical y, we hypothesized that intraoperative stress, hemorheological indices, postoperative immune function, and incidence of postoperative complications would be more favorable using a combined nerve block compared with previous anesthesia methods. OBJECTIVE:To investigate the effects of a combined nerve block on intraoperative stress and postoperative immune function in elderly patients subjected to total hip replacement. METHODS:This is a prospective, single-center, randomized control ed, open-label trial, which wil be performed at Qingdao University Affiliated Hospital, China. A total of 120 elderly patients scheduled to undergo total hip replacement wil be randomly assigned to undergo a combined nerve block (involving lower lumbar plexus, sciatic nerve, and paraspinal nerve L1-2) (experimental group, n=60), or general anesthesia (control group, n=60). Al patients wil be fol owed up for 3 months. The primary outcome wil be serum cortisol concentration during surgery, as a measure of intraoperative stress. Secondary outcomes include serum cortisol concentration prior to anesthesia, and prior to and immediately after surgery;blood glucose level prior to anesthesia, and prior to, during, and after surgery, used to evaluate stress during different times. In addition, immune function-related indices including absolute leukocyte count, absolute neutrophil count, interleukin-1, interleukin-6, tumor necrosis factor-α, and T-lymphocyte subset levels prior to anesthesia, immediately after surgery, 1, 3, 7 days, and 3 months after surgery, wil be used to evaluate patients’ immune function after surgery. Hemorheological indices including electrocardiogram, pulse, systolic pressure, diastolic pressure, heart rate, blood gas analysis prior to anesthesia, and during and after surgery wil be used to investigate changes in blood-related indices. Lastly, incidence of adverse events 1, 3, 7 days, and 3 months after surgery wil be used to evaluate postoperative complications. This trial has been approved by Ethics Committee, Qingdao University Affiliated Hospital, China (approval number QHY1017D) and wil be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. DISCUSSION:This study wil investigate the effects of a combined nerve block versus general anesthesia on intraoperative stress and postoperative immune function in elderly patients who undergo total hip replacement. This study wil provide objective evidence for selection of anesthesia method for total hip replacement in the elderly, with the aim of reducing intraoperative risks and postoperative complications. Signed informed consent wil be obtained from the patients or their relatives. TRIAL REGISTRATION:This trial was registered at ClinicalTrials.gov identifier:NCT02884388 on 19 August 2016.
展开▼
