RecruitingNot ApplicableNCT04209218

Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

Impact of Intraoperative Blood Pressure Management and Dexamethasone on Patient's Outcomes After Lung Cancer Surgery: A 2 × 2 Factorial Randomized Controlled Trial


Sponsor

Peking University First Hospital

Enrollment

1,988 participants

Start Date

Apr 7, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 90 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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.

Interventions

DRUGDexamethasone

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

OTHERTargeted blood pressure management

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.


Locations(1)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT04209218


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