Prophylactic Penehyclidine Hydrochloride Inhalation and 3-year Outcome After Surgery (NCT03868709) | Clinical Trial Compass
CompletedPhase 4
Prophylactic Penehyclidine Hydrochloride Inhalation and 3-year Outcome After Surgery
China864 participantsStarted 2019-03-12
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 receptors. A previous randomized controlled trial tested the effect of prophylactic penehyclidine inhalation on the incidence of PPCs in high-risk patients. The purpose of this 3-year follow-up study is to investigate whether prophylactically penehyclidine hydrochloride inhalation can affect the 3-year outcomes of patients recruited in the previous randomized controlled trial.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age of 50 years or over;
✓. Scheduled to undergo open or laparoscope assisted upper abdominal or intrathoracic surgery;
✓. The expected duration of surgery is 2 hours or longer;
✓. Identified 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 h;
✕. Preoperative history of prostatic 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
Duration of overall survival within 3 years after surgery
Timeframe: From the day of surgery until the end of the 3rd year after surgery