Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

Peking University

Status: Enrolling

Conditions: Postoperative Complications; Surgery; Overall Survival; Lung Cancer; Blood Pressure Management; Dexamethasone

Treatments: Drug: Placebo; Other: Routine blood presure management; Drug: Dexamethasone; Other: Targeted blood pressure management

Study type: Interventional

Funder types: Other

Identifiers

NCT04209218

2019-234

Details and patient eligibility

About

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.

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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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

Enrollment: 1,988 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,988 participants in 4 patient groups, including a placebo group

Routine blood pressure management + placebo

Placebo Comparator group

Description:

Blood pressure is maintained according to routine practice. Placebo (normal saline 2 ml) is administered before anesthesia induction.

Treatment:

Drug: Placebo

Other: Routine blood presure management

Routine blood pressure management + dexamethasone

Experimental group

Description:

Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction.

Treatment:

Drug: Dexamethasone

Other: Routine blood presure management

Targeted blood pressure management + placebo

Experimental group

Description:

Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.

Treatment:

Other: Targeted blood pressure management

Drug: Placebo

Targeted blood pressure management + dexamethasone

Experimental group

Description:

Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.

Treatment:

Drug: Dexamethasone

Other: Targeted blood pressure management