Actively Recruiting

Phase Not Applicable
Age: 50Years - 90Years
All Genders
ID04209218

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

Led by Peking University First Hospital · Updated on 2025-07-31

1988

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how managing blood pressure during surgery and the use of dexamethasone may influence early and long-term outcomes in patients undergoing surgery for non-small cell lung cancer (NSCLC). Surgery is the main treatment for NSCLC, but complications after surgery remain high and long-term survival is challenging. This study explores if avoiding low blood pressure during surgery and giving dexamethasone can reduce complications and improve survival. The trial compares four groups: routine blood pressure management with placebo, routine blood pressure management with dexamethasone, targeted blood pressure management within ±10% of baseline with placebo, and targeted blood pressure management with dexamethasone. Dexamethasone is given before anesthesia induction, and blood pressure is either managed routinely or tightly controlled throughout surgery. The study uses a 2 × 2 factorial randomized design to assess these interventions. Participants will be monitored for organ injury and complications within 5 days after surgery and followed for up to 5 years to assess overall survival and cancer-related outcomes. Researchers will collect data on intensive care unit admissions, mechanical ventilation duration, hospital stay length, and mortality rates. This comprehensive follow-up aims to evaluate both short-term safety and long-term survival benefits associated with the study interventions.

CONDITIONS

Brief Title

Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

Who Can Participate

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo lung cancer surgery during which blood pressure is managed either routinely or within ±10% of baseline. They receive either dexamethasone or placebo before anesthesia induction to potentially reduce postoperative complications.

1 surgical procedure and immediate post-operative monitoring

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for organ injury, complications, and recovery outcomes up to 30 days after surgery.

Approximately 6 post-operative visits

Long-term Monitoring

Duration - Up to 5 years after surgery

Participants are followed to assess overall survival and cancer-related outcomes after surgery.

Annual visits or as scheduled for long-term outcome assessment

Trial Site Locations

Total: 1 location

1

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

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD, PhD

W

Wen-Wen Huang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

4

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Published Research Related To This Trial

Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.

Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...

https://pubmed.ncbi.nlm.nih.gov/30207593

2nd ESMO Consensus Conference on Lung Cancer: early-stage non-small-cell lung cancer consensus on diagnosis, treatment and follow-up.

J Vansteenkiste, L Crinò, C Dooms...

https://pubmed.ncbi.nlm.nih.gov/24562446

Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery.

Edward J Mascha, Dongsheng Yang, Stephanie Weiss...

https://pubmed.ncbi.nlm.nih.gov/25929547