Blood Pressure Management, Dexamethasone, Lung Cancer, Overall Survival, Postoperative Complications, Surgery
Conditions
Keywords
Lung Cancer, Radical Resection, Blood Pressure Management, Dexamethasone, Overall Survival, Postoperative Complications
Brief summary
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.
Detailed description
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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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.
Interventions
DRUGDexamethasone
Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Blood pressure is maintained within ±10% from baseline.
DRUGPlacebo
Placebo (2 ml normal saline) is administered before anesthesia induction.
OTHERRoutine blood presure management
Blood pressure is maintained according to routine practice.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
For dexamethasone administration, all participants, care providers, investigators, and outcomes assessors are masked. For blood pressure management, participants and outcome assessors are masked.
Intervention model description
A 2 × 2 factorial randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Aged \>50 years but \<90 years. * Diagnosed as resectable primary non-small cell lung cancer (stage IA-IIIA) and scheduled for radical surgery with an expected duration of \>2 hours. * Agree to participate in this study and sign the informed consent.
Exclusion criteria
* Clinical examinations suggest non-resectable lung cancer or patients scheduled for a biopsy surgery. * Recurrent or metastatic lung cancer. * History of cancer or complicated with cancer in other organs. * Long-term exposure to glucocorticoids or other immunosuppressant(s) due to autoimmune disease or organ transplantation. * Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg); or requirement of vasopressors to maintain blood pressure. * Persistent atrial fibrillation, or acute cardiovascular events (acute coronary syndrome, stroke, or congestive heart failure) within 3 months. * Severe hepatic dysfunction (Child-Pugh C) or renal failure (requirement of renal replacement therapy). * Any other circumstances considered unsuitable for study participation by attending physicians or investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival after surgery | Up to 5 years after surgery | Overall survival after surgery |
| Incidence of organ injury and complications within 5 days after surgery (sub-study). | Up to 5 days after surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival after surgery | Up to 5 years after surgery | Event-free survival after surgery |
| Rate of intensive care unit (ICU) admission after surgery (sub-study) | During the day of surgery | Rate of ICU admission after surgery |
| Rate of ICU admission with endotracheal intubation after surgery (sub-study) | During the day of surgery | Rate of ICU admission with endotracheal intubation after surgery |
| Duration of mechanical ventilation in ICU after surgery (sub-study) | Up to 30 days after surgery | Duration of mechanical ventilation in ICU after surgery |
| Length of stay in ICU after surgery (sub-study) | Up to 30 days after surgery | Length of stay in ICU after surgery |
| Incidence of organ injury within 5 days after surgery (sub-study) | Up to 5 days after surgery | 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). |
| Incidence of complications within 30 days after surgery (sub-study) | Up to 30 days after surgery | 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. |
| Length of stay in hospital after surgery (sub-study) | Up to 30 days after surgery | Length of stay in hospital after surgery |
| Rate of 30-day all-cause mortality (sub-study) | Up to 30 days after surgery | Death due to any cause within 30 days after surgery |
| Recurrence-free survival after surgery | Up to 5 years after surgery | Recurrence-free survival after surgery |
| Cancer-specific survival after surgery | Up to 5 years after surgery | Cancer-specific survival after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival after surgery in cancer patients | Up to 5 years after surgery | Event-free survival after surgery in cancer patients |
| 30-item quality of life in 1-, 2-, and 3-year survivors | At the end of the 1st, 2nd, and 3rd year after surgery | Quality of life is assessed with the 30-item Core Quality of Life Questionnaire (QLQ-C30), which assess functioning and symptom scales. The score of each scale ranges from 0 to 100, with higher score indicating better function or worse symptom. |
| 13-item quality of life in 1-, 2-, and 3-year survivors | At the end of the 1st, 2nd, and 3rd year after surgery | Quality of life is assessed with the 13-item Quality of Life Questionnaire-Lung Cancer Module (QLQ LC-13), which assess symptom scales. The score of each scale ranges from 0 to 100, with higher score indicating worse symptom. The QLQ LC-13 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. |
| Pain score within 3 days after surgery (sub-study) | Up to 3 days after surgery | Pain score is assessed with the Numeric Rating Scale, an 11-point scale where 0=no pain and 10=the worst pain. |
| Subjective sleep quality score within 3 days after surgery (sub-study) | Up to 3 days after surgery | Subjective sleep quality is assessed with the Numeric Rating Scale, an 11-point scale where 0=the best sleep and 10=the worst sleep. |
| Cancer-specific survival after surgery in cancer patients | Up to 5 years after surgery | Cancer-specific survival after surgery in cancer patients |
| Recurrence-free survival after surgery in cancer patients | Up to 5 years after surgery | Recurrence-free survival after surgery in cancer patients |
| Overall survival after surgery in cancer patients | Up to 5 years after surgery | Overall survival after surgery in cancer patients |
Countries
China
Contacts
Primary ContactDong-Xin Wang, MD, PhD
Backup ContactWen-Wen Huang, MD
Outcome results
None listed