Prophylactic Penehyclidine Hydrochloride Inhalation and 3-year Outcome After Surgery

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital

Criteria

Inclusion Criteria:

1. Age of 50 years or over;

2. Scheduled to undergo open or laparoscope assisted upper abdominal or intrathoracic surgery;

3. The expected duration of surgery is 2 hours or longer;

4. Identified at high risk of PPCs according to the ARISCAT risk score (ARISCAT predictive score ≥45).

Exclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical classification ≥ IV or the expected survival duration ≤ 24 h;

2. Preoperative history of prostatic hypertrophy or glaucoma;

3. History of myocardial infarction, severe heart dysfunction (New York Heart Association functional classification ≥ 3) or tachyarrhythmia within one year;

4. Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within one month before surgery;

5. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);

6. History of acute stroke within three months before surgery;

7. Refuse to participate in the study or unable to cooperate with the inhalation therapy;

8. Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial.