About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

Dexamethasone
Drug
Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Targeted blood pressure management
Other intervention
Blood pressure is maintained within ±10% from baseline.
Placebo
Drug
Placebo (2 ml normal saline) is administered before anesthesia induction.
Routine blood presure management
Other intervention
Blood pressure is maintained according to routine practice.

Treatment groups

1,988 Participants

are divided into 4 treatment groups

Group A: Routine blood pressure management + placeboPlacebo comparator 2 interventions

Group B: Routine blood pressure management + dexamethasoneExperimental treatment 2 interventions

Group C: Targeted blood pressure management + placeboExperimental treatment 2 interventions

Group D: Targeted blood pressure management + dexamethasoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival after surgery

Time frame

Up to 5 years after surgery

2

Incidence of organ injury and complications within 5 days after surgery (sub-study).

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.

Time frame

Up to 5 days after surgery.

Secondary outcomes

1

Recurrence-free survival after surgery

Time frame

Up to 5 years after surgery

2

Cancer-specific survival after surgery

Time frame

Up to 5 years after surgery

3

Event-free survival after surgery

Time frame

Up to 5 years after surgery

4

Rate of intensive care unit (ICU) admission after surgery (sub-study)

Rate of ICU admission after surgery

Time frame

During the day of surgery

Other outcomes

1

Overall survival after surgery in cancer patients

Time frame

Up to 5 years after surgery

2

Recurrence-free survival after surgery in cancer patients

Time frame

Up to 5 years after surgery

3

Cancer-specific survival after surgery in cancer patients

Time frame

Up to 5 years after surgery

4

Event-free survival after surgery in cancer patients

Time frame

Up to 5 years after surgery

Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts