Preventive Effects of Penehyclidine Hydrochloride Inhalation on Postoperative Pulmonary Complications

• Status: Completed
• Trial end date: 2018-12-10
• 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, 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.

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

Details

• Lead Sponsor: Peking University First Hospital

Criteria

Inclusion Criteria:

1. Age >50 years;

2. 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;

3. Judged to be 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 hours;

2. Preoperative history of symptomatic 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.