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Recruiting Not applicable

Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

NCT04209218 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2020-04-07
Last updated
2025-07-31

Condition(s) studied

Lung CancerSurgeryBlood Pressure ManagementDexamethasoneOverall SurvivalPostoperative Complications

Investigational drug(s) / intervention(s)

Dexamethasone →Targeted blood pressure managementPlaceboRoutine blood presure management

Dexamethasone: Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.

Targeted blood pressure management: Blood pressure is maintained within ±10% from baseline.

Placebo: Placebo (2 ml normal saline) is administered before anesthesia induction.

Routine blood presure management: Blood pressure is maintained according to routine practice.

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04209218 on ClinicalTrials.gov ↗ ← All trials in China