PDF(Pubmed)
Abstract：
In addition to general anesthesia and mechanical ventilation, robotic-assisted laparoscopic radical prostatectomy (RALP) necessitates maintaining a capnoperitoneum and placing the patient in a pronounced downward tilt (Trendelenburg position). While the effects of the resulting fluid shift on the cardiovascular system seem to be modest and well tolerated, the effects on the brain and the blood-brain barrier have not been thoroughly investigated. Previous studies indicated that select patients showed an increase in the optic nerve sheath diameter (ONSD), detected by ultrasound during RALP, which suggests an elevation in intracranial pressure. We hypothesize that the intraoperative fluid shift results in endothelial dysfunction and reduced cerebral clearance, potentially leading to transient neuronal damage. This prospective, monocentric, non-randomized, controlled clinical trial will compare RALP to conventional open radical prostatectomy (control group) in a total of 50 subjects. The primary endpoint will be the perioperative concentration of neurofilament light chain (NfL) in blood using single-molecule array (SiMoA) as a measure for neuronal damage. As secondary endpoints, various other markers for endothelial function, inflammation, and neuronal damage as well as the ONSD will be assessed. Perioperative stress will be evaluated by questionnaires and stress hormone levels in saliva samples. Furthermore, the subjects will participate in functional tests to evaluate neurocognitive function. Each subject will be followed up until discharge. Conclusion: This trial aims to expand current knowledge as well as to develop strategies for improved monitoring and higher safety of patients undergoing RALP. The trial was registered with the German Clinical Trials Register DRKS00031041 on 11 January 2023.
摘要：
除了全身麻醉和机械通气，机器人辅助腹腔镜根治性前列腺切除术(RALP)需要维持腹膜,并使患者处于明显的向下倾斜位置(Trendelenburg位置).虽然所产生的液体移位对心血管系统的影响似乎是适度的，并且耐受性良好，对大脑和血脑屏障的影响尚未得到彻底研究。先前的研究表明，选定的患者显示视神经鞘直径（ONSD）增加，在RALP期间通过超声检测到，这表明颅内压升高。我们假设术中液体移位导致内皮功能障碍和脑清除减少，可能导致短暂的神经元损伤。这个未来,单心,非随机化，对照临床试验将在总共50名受试者中比较RALP与常规开放式前列腺癌根治术（对照组）。主要终点将是使用单分子阵列(SiMoA)作为神经元损伤的量度的血液中神经丝轻链(NfL)的围手术期浓度。作为次要终点，内皮功能的各种其他标志物，炎症,和神经元损伤以及ONSD将被评估。将通过问卷调查和唾液样本中的应激激素水平来评估围手术期应激。此外，受试者将参加功能测试以评估神经认知功能。每个受试者将被跟踪直到出院。结论：该试验旨在扩大现有知识，并制定策略，以改善接受RALP的患者的监测和更高的安全性。该试验于2023年1月11日在德国临床试验登记处DRKS00031041注册。
