Clinical trial NCT04209218: Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery
Official title: Impact of Intraoperative Blood Pressure Management and Dexamethasone on Patient's Outcomes After Lung Cancer Surgery: A 2 × 2 Factorial Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Surgery
Blood Pressure Management
Dexamethasone
Overall Survival
Postoperative Complications
Keywords: Lung Cancer
Radical Resection
Blood Pressure Management
Dexamethasone
Overall Survival
Postoperative Complications
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 1988
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 2 × 2 factorial randomized controlled trial
Primary purpose: PREVENTION

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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival after surgery
timeFrame: Up to 5 years after surgery
measure: Incidence of organ injury and complications within 5 days after surgery (sub-study).
timeFrame: Up to 5 days after surgery.
Secondary outcomes:
measure: Recurrence-free survival after surgery
timeFrame: Up to 5 years after surgery
measure: Cancer-specific survival after surgery
timeFrame: Up to 5 years after surgery
measure: Event-free survival after surgery
timeFrame: Up to 5 years after surgery
measure: Rate of intensive care unit (ICU) admission after surgery (sub-study)
timeFrame: During the day of surgery
measure: Rate of ICU admission with endotracheal intubation after surgery (sub-study)
timeFrame: During the day of surgery
measure: Duration of mechanical ventilation in ICU after surgery (sub-study)
timeFrame: Up to 30 days after surgery
measure: Length of stay in ICU after surgery (sub-study)
timeFrame: Up to 30 days after surgery
measure: Incidence of organ injury within 5 days after surgery (sub-study)
timeFrame: Up to 5 days after surgery
measure: Incidence of complications within 30 days after surgery (sub-study)
timeFrame: Up to 30 days after surgery
measure: Length of stay in hospital after surgery (sub-study)
timeFrame: Up to 30 days after surgery
measure: Rate of 30-day all-cause mortality (sub-study)
timeFrame: Up to 30 days after surgery
Other outcomes:
measure: Overall survival after surgery in cancer patients
timeFrame: Up to 5 years after surgery
measure: Recurrence-free survival after surgery in cancer patients
timeFrame: Up to 5 years after surgery
measure: Cancer-specific survival after surgery in cancer patients
timeFrame: Up to 5 years after surgery
measure: Event-free survival after surgery in cancer patients
timeFrame: Up to 5 years after surgery
measure: 30-item quality of life in 1-, 2-, and 3-year survivors
timeFrame: At the end of the 1st, 2nd, and 3rd year after surgery
measure: 13-item quality of life in 1-, 2-, and 3-year survivors
timeFrame: At the end of the 1st, 2nd, and 3rd year after surgery
measure: Pain score within 3 days after surgery (sub-study)
timeFrame: Up to 3 days after surgery
measure: Subjective sleep quality score within 3 days after surgery (sub-study)
timeFrame: Up to 3 days after surgery
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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