Yan Ting, Liang Xin-Quan, Wang Tong, Li Wei-Ou, Li Hui-Juan, Zhu Sai-Nan, Wang Dong-Xin
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, 100034, China.
Department of Anesthesiology, Aerospace Central Hospital, No.15 Yuquan Street, Haidian District, Beijing, 100049, China.
Trials. 2017 Nov 28;18(1):571. doi: 10.1186/s13063-017-2315-7.
Postoperative pulmonary complications (PPCs) are major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery. Using effective strategies to prevent its occurrence is essential to improve outcome. However, despite various efforts, the incidence of PPCs remains elevated in high-risk patients. Anticholinergic inhalation is used to reduce high airway resistance and improve pulmonary function; it may be helpful to decrease the risk of PPCs. Penehyclidine is a long-acting anticholinergic agent which selectively blocks M1 and M3 receptors. We hypothesize that, in high-risk patients, prophylactic penehyclidine inhalation may decrease the incidence of PPCs.
This is a randomized, double-blind, placebo-controlled trial with two parallel arms. A total of 864 patients at high risk of PPCs will be enrolled and randomized to receive prophylactic inhalation of either penehyclidine or placebo (water for injection). Study drug inhalation will be administered from the night (7 pm) before surgery until the second day after surgery, in an interval of every 12 hours. The primary outcome is the incidence of PPCs within 30 days after surgery. Secondary outcomes include the time to onset of PPCs (from end of surgery to first diagnosis of PPCs), the number of PPCs (indicates the number of diagnosed individual PPCs), the incidence of postoperative extrapulmonary complications, the length of stay in hospital after surgery, and the 30-day all-cause mortality.
Results of the present study will provide evidence to guide clinical practice in using prophylactic inhalation of an anticholinergic to prevent PPCs in high-risk patients.
The study was registered prospectively in Chinese Clinical Trial Registry ( www.chictr.org.cn , ChiCTR-IPC-15006603 ) on 14 May 2015 and retrospectively in ClinicalTrials.gov ( NCT02644876 ) on 30 December 2015.
术后肺部并发症（PPCs）是手术患者发病、死亡及住院时间延长的主要原因。采用有效的预防策略对改善预后至关重要。然而，尽管采取了各种措施，高危患者中PPCs的发生率仍然居高不下。抗胆碱能吸入用于降低高气道阻力和改善肺功能；这可能有助于降低PPCs的风险。戊乙奎醚是一种长效抗胆碱能药物，可选择性阻断M1和M3受体。我们假设，在高危患者中，预防性吸入戊乙奎醚可能会降低PPCs的发生率。
这是一项随机、双盲、安慰剂对照试验，分为两个平行组。总共864例有PPCs高危风险的患者将被纳入并随机分组，接受预防性吸入戊乙奎醚或安慰剂（注射用水）。研究药物吸入将在手术前一晚（晚上7点）开始，持续至术后第二天，每12小时一次。主要结局是术后30天内PPCs的发生率。次要结局包括PPCs的发病时间（从手术结束到首次诊断为PPCs的时间）、PPCs的数量（表示诊断出的个体PPCs的数量）、术后肺外并发症的发生率、术后住院时间以及30天全因死亡率。
本研究结果将为指导临床实践中使用预防性抗胆碱能吸入预防高危患者的PPCs提供证据。
该研究于2015年5月14日在中国临床试验注册中心（www.chictr.org.cn，ChiCTR-IPC-15006603）进行前瞻性注册，并于2015年12月30日在ClinicalTrials.gov（NCT02644876）进行回顾性注册。
