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:随机对照临床试验方案

发布时间：2018-03-05 22:00

本文选题：组织工程　切入点：髋关节　出处：《中国组织工程研究》2016年39期 　论文类型：期刊论文

【摘要】：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)。
[Abstract]:Background: the effects of noxious stimuli such as anesthesia and surgery on stress response and hemorheology in elderly patients with total hip replacement are obvious. In the past, the main anesthetic methods of hip replacement in elderly patients were general anesthesia, lumbar puncture anesthesia and epidural anesthesia. The elderly patients with total hip replacement are more suitable for combined nerve block anesthesia. Objective: to observe the effect of combined nerve block anesthesia on stress and immune function after total hip arthroplasty in elderly patients. Methods: the study was prospective, single center, randomized controlled, open clinical trial, in Qinghai, China. 120 elderly patients with total hip replacement were randomly divided into two groups, 60 cases in each group. The experimental group received combined nerve block anesthesia during operation, including lumbar plexus of lower extremity. The L1-2 paravertebral nerve block was used in the control group and the general anesthesia was used in the control group for 3 months. The main indexes of the experiment were the concentration of serum cortisol in the operation to evaluate the stress response during the operation, and the observation index was before anesthesia. The serum cortisol concentration before, immediately after replacement, and the blood glucose concentration before, during, and immediately after replacement were used to evaluate the stress response of the patients. WBC, neutrophil absolute value, interleukin-1 and interleukin 6, tumor necrosis factor 伪 -T lymphocyte subsets, immune function of the patients after replacement were evaluated at 1 ~ 3 ~ 3 days and 3 months after replacement, and hemodynamic parameters included pre-anesthesia and intraoperative hemodynamics. Electrocardiogram, pulse, systolic blood pressure, diastolic blood pressure, heart rate and blood gas were measured immediately after replacement to observe the changes of blood related parameters, and the incidence of adverse events occurred 1 ~ 3 days and 3 months after replacement. The study was approved by the Medical Ethics Committee of the affiliated Hospital of Qinghai University of China (approval No.: QHY1017D). The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Who has informed consent to both the content of the trial and the course of the treatment, The effects of combined nerve block anesthesia and general anesthesia on stress and immune function in elderly patients with total hip replacement were compared. The purpose of this study was to provide objective basis for the selection of various anesthetic methods in elderly total hip arthroplasty (THR) so as to reduce the intraoperative risk. Reduce the incidence of early complications after replacement. Trial registration information: the trial was registered at the North American Clinical trial Registry NCT02884388on August 19th 2016.
【作者单位】：青海大学附属医院麻醉科;青海大学附属医院关节科;青海大学附属医院疼痛科;
【分类号】：R614

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