Status:
COMPLETED
Prophylactic Penehyclidine Hydrochloride Inhalation and 3-year Outcome After Surgery
Lead Sponsor:
Peking University First Hospital
Conditions:
Postoperative Complications
Long-term Outcome
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief 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 patient...
Detailed Description
Postoperative pulmonary complications (PPCs) are major causes of postoperative morbidity, mortality, and prolonged hospital stay. The incidence of PPCs was found to vary from 2 to 19%, but this rate m...
Eligibility Criteria
Inclusion
- 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
- 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);
- History of acute stroke within three months before surgery;
- Refuse to participate in the study or unable to cooperate with the inhalation therapy;
- 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.
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
864 Patients enrolled
Trial Details
Trial ID
NCT03868709
Start Date
March 12 2019
End Date
December 1 2021
Last Update
April 16 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034