Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

NCT04209218 | Recruiting DMC

• 1 other identifier: 2019-234
• Study Type: interventional
• Target: 1,988
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Lung Cancer; Radical Resection; Blood Pressure Management; Dexamethasone; Overall Survival; Postoperative Complications

Outcome Measures

Primary Outcomes (2)

• Overall survival after surgery

  Overall survival after surgery

  Up to 5 years after surgery

• 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.

  Up to 5 days after surgery.

Secondary Outcomes (11)

• Recurrence-free survival after surgery

  Up to 5 years after surgery

• Cancer-specific survival after surgery

  Up to 5 years after surgery

• Event-free survival after surgery

  Up to 5 years after surgery

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

  During the day of surgery

• Rate of ICU admission with endotracheal intubation after surgery (sub-study)

  During the day of surgery

Other Outcomes (8)

• Overall survival after surgery in cancer patients

  Up to 5 years after surgery

• Recurrence-free survival after surgery in cancer patients

  Up to 5 years after surgery

• Cancer-specific survival after surgery in cancer patients

  Up to 5 years after surgery

Study Arms (4)

Routine blood pressure management + placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Other: Routine blood presure management

Routine blood pressure management + dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone; Other: Routine blood presure management

Targeted blood pressure management + placebo

EXPERIMENTAL

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

Other: Targeted blood pressure management; Drug: Placebo

Targeted blood pressure management + dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone; Other: Targeted blood pressure management

Interventions

Dexamethasone DRUG

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

Also known as: Glucocorticoids

Routine blood pressure management + dexamethasone; Targeted blood pressure management + dexamethasone

Targeted blood pressure management OTHER

Blood pressure is maintained within ±10% from baseline.

Targeted blood pressure management + dexamethasone; Targeted blood pressure management + placebo

Placebo DRUG

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

Also known as: Normal saline

Routine blood pressure management + placebo; Targeted blood pressure management + placebo

Routine blood presure management OTHER

Blood pressure is maintained according to routine practice.

Routine blood pressure management + dexamethasone; Routine blood pressure management + placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100034, China

RECRUITING

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MeSH Terms

Conditions

Lung Neoplasms; Postoperative Complications

Interventions

Dexamethasone; Glucocorticoids; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

86 (10) 83572784; wangdongxin@hotmail.com

Wen-Wen Huang, MD

CONTACT

86 (10) 83572460; hww9215@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: For dexamethasone administration, all participants, care providers, investigators, and outcomes assessors are masked. For blood pressure management, participants and outcome assessors are masked.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Anaesthesiology and Critical Care Medicine

Model Details: A 2 × 2 factorial randomized controlled trial

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 24, 2019
• Study Start: April 7, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)