背景:老年全髋关节置换后患者常并发认知功能障碍,具体机制不清.有研究表明,七氟烷可调节脑内认知功能障相关因子碱性成纤维细胞生长因子的表达,但是否能降低髋关节置换后患者认知功能障的发生尚未见报道.试验假设采用腰丛-坐骨神经阻滞复合七氟烷的麻醉方案,可有效降低老年髋关节置换患者置换后认知功能障碍的发生率.目的:观察采用腰丛-坐骨神经阻滞复合七氟烷的麻醉方案对老年髋关节置换患者置换后认知功能障碍的影响.方法:研究为前瞻性、单中心、开放性、随机对照临床试验,在中国青海省,青海大学附属医院完成.纳入老年单侧全髋关节置换患者70例,随机分为2组,观察组术中以腰丛及坐骨神经阻滞后行气管插管全身麻醉,配合采取吸入七氟烷麻醉维持;对照组术中采取常规气管插管全身麻醉,配合采用静脉给予丙泊酚麻醉维持,置换后1,3 d随访检测患者.试验的主要观察指标为两组患者置换前、置换后1,3 d以简易精神状态量表评分评估患者认知功能;试验的次要观察指标为两组患者置换前、置换后1,3 d以蒙特利尔认知评估量表对患者的评分,血清碱性成纤维细胞生长因子水平;术中失血量及手术时间;其他观察指标为患者术中、置换后1,3 d的不良反应发生率.试验经中国青海省青海大学附属医院伦理委员会批准.研究符合世界医学会制定的《赫尔辛基宣言》的要求.参与者本人对治疗方案和过程均知情同意,并签署知情同意书.讨论:试验旨在证实腰丛-坐骨神经阻滞复合七氟烷可改善老年髋关节置换患者置换后认知功能障碍,并观察血清碱性成纤维细胞生长因子的表达变化,进一步探讨其治疗机制.%BACKGROUND: Elderly patients after total hip arthroplasty often suffer from postoperative cognitive dysfunction, but the precise mechanism remains unclear. Sevoflurane has been shown to regulate the expression of basic fibroblast growth factor in the brain. However, it is poorly understood whether sevoflurane can decrease cognitive dysfunction after hip arthroplasty. We assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively decrease the incidence of cognitive dysfunction in elderly patients after hip arthroplasty. OBJECTIVE: To investigate the effects of lumbar plexus-sciatic nerve block combined with sevoflurane on cognitive function in elderly patients after hip arthroplasty.METHODS: A prospective, single-center, open-label, randomized, controlled, clinical trial will be finished at Qinghai University Affiliated Hospital, China. Seventy elderly patients undergoing unilateral total hip arthroplasty will be randomized into two groups. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance. All patients will be followed up at 1 and 3 days after replacement. The primary outcome:Mini-Mental State Examination will be used to assess cognitive function at baseline, 1 and 3 days postoperatively. The secondary outcomes will be Montreal Cognitive Assessment, serum basic fibroblast growth factor expression at baseline,1 and 3 days postoperatively; intraoperative blood loss and operation time; incidence of adverse effects intraoperatively,1 and 3 days postoperatively. This trial has been approved by the Ethics Committee of Qinghai University Affiliated Hospital, China, and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants prior to the trial.DISCUSSION: This trial will verify that lumbar plexus-sciatic nerve block combined with sevoflurane can improve cognitive dysfunction in elderly patients after hip arthroplasty, observe the changes in serum basic fibroblast growth factor level, and further explore its therapeutic mechanism.
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