Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2315-7) contains supplementary material, which is available to authorized users.