Department of Anaesthesiology, University Hospital Aachen, RWTH, Aachen, Germany.
Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180.
Strategies to protect the brain from postoperative delirium (POD) after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i) by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABA)A receptor and (ii) through beneficial anesthetic and organ-protective effects.
An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM), in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome) is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years) and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane).
EudraCT Identifier: 2009-017153-35; ClinicalTrials.gov Identifier: NCT01199276.
迫切需要寻找保护髋部骨折术后患者（POD）大脑的策略。谵妄的发展通常与独立能力丧失、功能恢复不良、发病率增加以及住院时间延长、护理设施出院和医疗保健费用增加有关。我们假设氙气可能通过以下两种方式减轻 POD 负担：（i）避免使用靶向γ-氨基丁酸（GABA）A 受体的药物进行麻醉；（ii）通过有益的麻醉和器官保护作用。
一项国际性、多中心、2 期、前瞻性、随机、双盲、平行组对照试验，旨在评估在全身麻醉下接受髋部骨折手术的老年患者中，氙气与七氟醚相比，术后 4 天内（主要结局）发生 POD 的发生率，采用意识模糊评估法（CAM）进行诊断。次要目标是比较氙气与七氟醚之间 POD 的发生率，评估术后第 5 天至出院期间 POD 的发生率，确定首次 POD 诊断的时间，评估 POD 的持续时间，评估术后患者生理状态的演变，评估恢复参数，收集初步数据以评估术后 POD 的经济影响，并收集安全性数据。如果患者年龄在 75 岁以上，并且在髋部骨折后 48 小时内计划进行髋部骨折手术，则符合纳入条件。此外，患者需要愿意并能够完成这项研究的要求，包括签署书面知情同意书。在 10 个参与中心共招募 256 名随机患者，即每组 128 名随机患者（分别接受氙气或七氟醚）。
EudraCT 标识符：2009-017153-35；ClinicalTrials.gov 标识符：NCT01199276。
