Preventive Effects of Penehyclidine Hydrochloride Inhalation on Postoperative Pulmonary Complicat… (NCT02644876) | Clinical Trial Compass
CompletedPhase 4
Preventive Effects of Penehyclidine Hydrochloride Inhalation on Postoperative Pulmonary Complications
China864 participantsStarted 2015-09-01
Plain-language summary
Postoperative pulmonary complications (PPCs) are major causes of postoperative morbidity, mortality, and prolonged hospital stay.The incidence of PPCs may be as high as 41% to 75% in high-risk patients. Bronchodilator is frequently used in high-risk patients to prevent PPCs. Penehyclidine is a new anticholinergic agent which selectively block M1 and M3, but not M2 receptors. A pilot study of the investigators showed that prophylactic penehyclidine inhalation reduced the incidence of bronchospasm and the use of aminophylline in elderly patients after long-duration surgery. The purpose of this study is to investigate whether prophylactically penehyclidine inhalation could decrease the incidence of PPCs in high-risk patients after major intrathoracic and upper intraabdominal surgery.
Who can participate
Age range51 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \>50 years;
✓. Scheduled to undergo upper abdominal or noncardiac thoracic surgery with expected duration ≥2 hours. For those who undergo laparoscopic or thoracoscopic surgery, the expected length of incision must be ≥5 cm;
✓. Judged to be at high risk of PPCs according to the ARISCAT risk score (ARISCAT predictive score ≥45).
Exclusion criteria
✕. American Society of Anesthesiologists (ASA) physical classification ≥IV or the expected survival duration ≤24 hours;
✕. Preoperative history of symptomatic hypertrophy or glaucoma;
✕. History of myocardial infarction, severe heart dysfunction (New York Heart Association functional classification ≥3) or tachyarrhythmia within one year;
✕. Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within one month before surgery;
✕. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);
What they're measuring
1
Incidence of postoperative pulmonary complications (PPCs)