聯(lián)合神經(jīng)阻滯麻醉對(duì)老年全髖關(guān)節(jié)置換術(shù)中應(yīng)激及置換后免疫功能的影響:隨機(jī)對(duì)照臨床試驗(yàn)方案
本文選題:組織工程 切入點(diǎn):髖關(guān)節(jié) 出處:《中國(guó)組織工程研究》2016年39期 論文類(lèi)型:期刊論文
【摘要】:背景:麻醉和手術(shù)等傷害性刺激對(duì)老年全髖關(guān)節(jié)置換術(shù)中應(yīng)激反應(yīng)和血流變指標(biāo)的影響較為明顯,容易使患者自身的生理機(jī)能受干擾,置換后免疫功能下降,影響置換后的髖關(guān)節(jié)功能恢復(fù)。以往老年患者行髖關(guān)節(jié)置換的麻醉方式主要為全身麻醉,腰椎穿刺麻醉及硬膜外麻醉等單一麻醉方法。以往有研究表明,老年全髖關(guān)節(jié)置換患者更適合采用聯(lián)合神經(jīng)阻滯麻醉,更安全可靠。目的:觀察聯(lián)合神經(jīng)阻滯麻醉對(duì)老年全髖關(guān)節(jié)置換術(shù)中應(yīng)激及置換后免疫功能的影響。方法:研究為前瞻性、單中心、隨機(jī)對(duì)照、開(kāi)放性臨床試驗(yàn),在中國(guó)青海,青海大學(xué)附屬醫(yī)院完成。將納入試驗(yàn)的老年全髖關(guān)節(jié)置換患者120例隨機(jī)分為2組,每組60例,試驗(yàn)組術(shù)中采取聯(lián)合神經(jīng)阻滯麻醉,包括下肢腰叢、坐骨神經(jīng)、L1-2椎旁神經(jīng)聯(lián)合阻滯麻醉,對(duì)照組術(shù)中采用全身麻醉,隨訪(fǎng)3個(gè)月。試驗(yàn)的主要觀察指標(biāo)為術(shù)中患者血清皮質(zhì)醇濃度評(píng)價(jià)術(shù)中應(yīng)激反應(yīng)情況;次要觀察指標(biāo)為麻醉前、術(shù)前,置換后即刻血清皮質(zhì)醇濃度,以及麻醉前、術(shù)前,術(shù)中、置換后即刻血糖濃度評(píng)價(jià)患者各時(shí)間段的應(yīng)激反應(yīng)情況;免疫功能相關(guān)指標(biāo)包括麻醉前,置換后即刻,置換后1,3,7 d及3個(gè)月患者白細(xì)胞、中性粒細(xì)胞絕對(duì)值、白細(xì)胞介素1,6、腫瘤壞死因子α、T淋巴細(xì)胞亞群水平,評(píng)價(jià)患者置換后的免疫功能;血流動(dòng)力學(xué)指標(biāo)包括麻醉前,術(shù)中,置換后即刻心電圖,脈搏,收縮壓、舒張壓、心率、血?dú)夥治鰴z測(cè)結(jié)果,觀察患者血液相關(guān)參數(shù)的變化;置換后1,3,7 d及3個(gè)月不良事件發(fā)生率,以評(píng)價(jià)患者置換后的并發(fā)癥發(fā)生情況。試驗(yàn)經(jīng)中國(guó)青海大學(xué)附屬醫(yī)院醫(yī)學(xué)倫理委員會(huì)批準(zhǔn)(審批號(hào):QHY1017D)。研究符合世界醫(yī)學(xué)會(huì)制定的《赫爾辛基宣言》的要求。參與者對(duì)試驗(yàn)內(nèi)容和治療過(guò)程均知情同意,并簽署知情同意書(shū)。討論:試驗(yàn)比較聯(lián)合神經(jīng)阻滯麻醉及全麻對(duì)老年全髖關(guān)節(jié)置換患者術(shù)中應(yīng)激及置換后免疫功能影響的差異,旨在為老年全髖關(guān)節(jié)置換術(shù)中多種麻醉方法的選擇提供客觀依據(jù),從而有利于降低術(shù)中風(fēng)險(xiǎn),減少置換后早期并發(fā)癥的發(fā)生。試驗(yàn)注冊(cè)信息:試驗(yàn)于2016年8月19日在北美臨床試驗(yàn)注冊(cè)中心注冊(cè)(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 偽 -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.
【作者單位】: 青海大學(xué)附屬醫(yī)院麻醉科;青海大學(xué)附屬醫(yī)院關(guān)節(jié)科;青海大學(xué)附屬醫(yī)院疼痛科;
【分類(lèi)號(hào)】:R614
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