Dexamethasone, Flurbiprofen Axetil and Long-term Survival After Lung Cancer Surgery
NCT03172988 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2019-03-05
Summary
Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Despite of advances in surgical techniques, the long-term survival rate of postoperative patient is far from optimal. In a recent retrospective cohort study of the applicants, 588 patients after surgery for non-small-cell lung cancer were followed up for a medium of 5.2 years. The results showed that perioperative use of dexamethasone was associated with prolonged survival; perioperative use of flurbiprofen axetil was also associated with a slightly longer survival but not statistically significant. Further analysis showed that combined administration of dexamethasone and flurbiprofen axetil had additive effect in prolonging survival. We hypothesize that, for patients undergoing surgery for non-small-cell lung cancer, perioperative administration of dexamethasone and flurbiprofen axetil may improve long-term survival. However, evidences from randomized controlled trials are still lacking in this aspect.
Conditions
- Carcinoma, Non-Small-Cell Lung
- Surgery
- Dexamethasone
- Flubiprofen Axetil
- Long-term Effects Secondary to Cancer Therapy in Adults
Interventions
- DRUG
-
Dexamethasone 10 mg is administered before anesthesia induction.
- DRUG
-
Normal saline
Normal saline 2 ml is administered before anesthesia induction.
- DRUG
-
Flurbiprofen axetil
Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
- DRUG
-
Lipid microsphere
Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
collaborator OTHER -
Peking University First Hospital
lead OTHER
Principal Investigators
-
Dong-Xin Wang, MD, PhD · Peking University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-02
- Primary Completion
- 2018-12-26
- Completion
- 2018-12-26
Countries
- China
Study Locations
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