Surgery is the front-line therapy for non-small cell lung cancer (NSCLC) but postoperative complications remains high and patients' long-term outcome is still challenging. In addition to surgery, anesthetic management particularly intraoperative blood pressure management and use of dexamethasone may affect patients' early and long-term outcomes after surgery for NSCLC. This study aims to investigate the impact of intraoperative blood pressure management and dexamethasone administration on early and long-term outcomes in patients undergoing surgery for lung cancer.
Surgical resection is the main treatment for patients with non-small cell lung cancer (NSCLC) and continuous efforts have been made to evolve surgical strategies and techniques. It has been now been realized that perioperative period is characterized with profound changes and anesthesia management may also affect outcomes of patients after cancer surgery. Even under well controlled conditions, blood pressure fluctuation frequently occurs during anesthesia and surgery. In previous studies, intraoperative hypotension was associated with increased risk of organ injuries (such as delirium, acute kidney injury, myocardial injury, and stroke) and higher 1-year mortality. Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery. In a recent trial, individualized intraoperative blood pressure management which avoided intraoperative hypotension decreased the incidence of postoperative organ injury when compared with routine practice. Avoiding intraoperative hypotension may also prolong survival after lung cancer surgery. However, evidences are lacking regarding this topic. Dexamethasone is frequently used for prevention of postoperative nausea and vomiting. Studies showed that a single low-dose dexamethasone has anti-inflammatory effect and can regulate immune function. It has been shown that perioperative dexamethasone can improve analgesia after surgery. In retrospective studies, perioperative low-dose dexamethasone was associated with less wound infection and improved long-term survival in patients after surgeries for pancreatic and lung cancer. It is hypothesized that intraoperative dexamethasone may reduce postoperative complications and improve long-term survival after lung cancer surgery. Interventional studies are required to confirm this hypothesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,988
Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Blood pressure is maintained within ±10% from baseline.
Placebo (2 ml normal saline) is administered before anesthesia induction.
Blood pressure is maintained according to routine practice.
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall survival after surgery
Overall survival after surgery
Time frame: Up to 5 years after surgery
Incidence of organ injury and complications within 5 days after surgery (sub-study).
Organ injury includes delirium, acute kidney injury and myocardial injury. Postoperative complications are generally defined as newly occurred medical conditions that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.
Time frame: Up to 5 days after surgery.
Recurrence-free survival after surgery
Recurrence-free survival after surgery
Time frame: Up to 5 years after surgery
Cancer-specific survival after surgery
Cancer-specific survival after surgery
Time frame: Up to 5 years after surgery
Event-free survival after surgery
Event-free survival after surgery
Time frame: Up to 5 years after surgery
Rate of intensive care unit (ICU) admission after surgery (sub-study)
Rate of ICU admission after surgery
Time frame: During the day of surgery
Rate of ICU admission with endotracheal intubation after surgery (sub-study)
Rate of ICU admission with endotracheal intubation after surgery
Time frame: During the day of surgery
Duration of mechanical ventilation in ICU after surgery (sub-study)
Duration of mechanical ventilation in ICU after surgery
Time frame: Up to 30 days after surgery
Length of stay in ICU after surgery (sub-study)
Length of stay in ICU after surgery
Time frame: Up to 30 days after surgery
Incidence of organ injury within 5 days after surgery (sub-study)
Organ injury includes delirium, acute kidney injury and myocardial injury. Delirium is assessed with the 3-minute diagnostic assessment for CAM-defined delirium (3D-CAM). Acute kidney injury is diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Myocardial injury is diagnosed according to the serum cardiac troponin I level (higher than upper normal limit of the hospital's clinical laboratory).
Time frame: Up to 5 days after surgery
Incidence of complications within 30 days after surgery (sub-study)
Postoperative complications are defined as new-onset medical events that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.
Time frame: Up to 30 days after surgery
Length of stay in hospital after surgery (sub-study)
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Rate of 30-day all-cause mortality (sub-study)
Death due to any cause within 30 days after surgery
Time frame: Up to 30 days after surgery
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