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Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery

Phase 2
Conditions
Primary lung cancer
Registration Number
JPRN-UMIN000012217
Lead Sponsor
Yokohama City University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
43
Inclusion Criteria

Not provided

Exclusion Criteria

1) Median sternotomy. 2) Combined resection of the chest wall excluding parietal pleura excision. 3) History of active infection. 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer. 5) Patients with glaucoma. 6) Patients with dysuria. 7) History of hypersensitivity to atropine or drugs similar to atropine. 8) Patients with interstitial pneumonia or pulmonary fibrosis. 9) Patients with arrhythmia requiring antiarrhythmic continuously. 10) Patients with thyropathy. 11) Patients with renal dysfunction needs blood purification therapy. 12) Patients with psychiatric disease. 13) Patients requiring systemic steroids medication. 14) Patients with uncontrolled diabetes mellitus. 15) Patients with uncontrolled hypertension. 16) Current or previous within the last 6 months history of severe heart diseases, cerebrovascular disease. 17) The pregnant and lactating female , female who has possibility of the pregnancy. 18) Patients who were judged inappropriate to entry this study by physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of cardiopulmonary complications within 1 year after surgery
Secondary Outcome Measures
NameTimeMethod
1)Improvement of pulmonary function before and after inhalation of Tiotropium 2)Rate of post operative complications excluding cardiopulmonary complications 3)3-years overall survival 4)Rate of adverse events 5)Evaluation of postoperative compliance
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