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Lung CancerNCT04209218

Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

A study testing Dexamethasone, Targeted blood pressure management and Routine blood presure management in people with Lung Cancer and Surgery, run by Peking University First Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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'… Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Lung Cancer, Surgery, Blood Pressure Management
What is being tested?
Dexamethasone, Targeted blood pressure management and Routine blood presure management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,988 participants
Where
1 siteChina
Study dates
7 Apr 2020to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD, PhD contact

86 (10) 83572784

wangdongxin@hotmail.com

Wen-Wen Huang, MD contact

86 (10) 83572460

hww9215@163.com

China1 site, 1 recruiting
  • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, MD, PhD, 86 (10) 83572784, wangdongxin@hotmail.com

    Yi-Bin Hua, MD, 86 (10) 83572460, huayibin@126.com

    Recruiting

Other trials in China

About this study

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

Read the detailed 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.

Being tested
Dexamethasone, Targeted blood pressure management, Placebo, Routine blood presure management
Keywords
Lung Cancer, Radical Resection, Blood Pressure Management, Dexamethasone, Overall Survival, Postoperative Complications
Medical subject headings
Lung Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Glucocorticoids

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

  • Targeted blood pressure managementOther

    Blood pressure is maintained within ±10% from baseline.

  • PlaceboDrug

    Also called Normal saline

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

  • Routine blood presure managementOther

    Blood pressure is maintained according to routine practice.

Study groups in NCT04209218
Study groupRoleWhat they receive
Routine blood pressure management + placeboPlacebo comparatorBlood pressure is maintained according to routine practice. Placebo (normal saline 2 ml) is administered before anesthesia induction.
Receives: Drug: Placebo; Other: Routine blood presure management
Routine blood pressure management + dexamethasoneExperimentalBlood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction.
Receives: Drug: Dexamethasone; Other: Routine blood presure management
Targeted blood pressure management + placeboExperimentalBlood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction.
Receives: Other: Targeted blood pressure management; Drug: Placebo
Targeted blood pressure management + dexamethasoneExperimentalBlood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
Receives: Drug: Dexamethasone; Other: Targeted blood pressure management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival after surgery

    Overall survival after surgery

    Measured: 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.

    Measured: Up to 5 days after surgery.

Secondary outcomes (11)
  1. Recurrence-free survival after surgery

    Recurrence-free survival after surgery

    Measured: Up to 5 years after surgery

  2. Cancer-specific survival after surgery

    Cancer-specific survival after surgery

    Measured: Up to 5 years after surgery

  3. Event-free survival after surgery

    Event-free survival after surgery

    Measured: Up to 5 years after surgery

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

    Rate of ICU admission after surgery

    Measured: During the day of surgery

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

    Rate of ICU admission with endotracheal intubation after surgery

    Measured: During the day of surgery

  6. Duration of mechanical ventilation in ICU after surgery (sub-study)

    Duration of mechanical ventilation in ICU after surgery

    Measured: Up to 30 days after surgery

  7. Length of stay in ICU after surgery (sub-study)

    Length of stay in ICU after surgery

    Measured: Up to 30 days after surgery

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

    Organ injury includes delirium, acute kidney injury and myocardial injury. Delirium is assessed with the 3-minute diagnostic assessment for CAM-defined delirium (3D-CAM). Acute kidney injury is diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Myocardial injury is diagnosed according to the serum cardiac troponin I level (higher than upper normal limit of the hospital's clinical laboratory).

    Measured: Up to 5 days after surgery

  9. Incidence of complications within 30 days after surgery (sub-study)

    Postoperative complications are defined as new-onset medical events that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.

    Measured: Up to 30 days after surgery

  10. Length of stay in hospital after surgery (sub-study)

    Length of stay in hospital after surgery

    Measured: Up to 30 days after surgery

  11. Rate of 30-day all-cause mortality (sub-study)

    Death due to any cause within 30 days after surgery

    Measured: Up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start7 Apr 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
A 2 × 2 factorial randomized controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,988 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04209218
Sponsor's protocol ID
2019-234
Status last verified
Jul 2025
First submitted
17 Dec 2019
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593
  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342
  • Sullivan R, Alatise OI, Anderson BO, Audisio R, Autier P, Aggarwal A, Balch C, Brennan MF, Dare A, D'Cruz A, Eggermont AM, Fleming K, Gueye SM, Hagander L, Herrera CA, Holmer H, Ilbawi AM, Jarnheimer A, Ji JF, Kingham TP, Liberman J, Leather AJ, Meara JG, Mukhopadhyay S, Murthy SS, Omar S, Parham GP, Pramesh CS, Riviello R, Rodin D, Santini L, Shrikhande SV, Shrime M, Thomas R, Tsunoda AT, van de Velde C, Veronesi U, Vijaykumar DK, Watters D, Wang S, Wu YL, Zeiton M, Purushotham A. Global cancer surgery: delivering safe, affordable, and timely cancer surgery. Lancet Oncol. 2015 Sep;16(11):1193-224. doi: 10.1016/S1470-2045(15)00223-5.

    PubMed 26427363
  • Vansteenkiste J, Crino L, Dooms C, Douillard JY, Faivre-Finn C, Lim E, Rocco G, Senan S, Van Schil P, Veronesi G, Stahel R, Peters S, Felip E; Panel Members. 2nd ESMO Consensus Conference on Lung Cancer: early-stage non-small-cell lung cancer consensus on diagnosis, treatment and follow-up. Ann Oncol. 2014 Aug;25(8):1462-74. doi: 10.1093/annonc/mdu089. Epub 2014 Feb 20.

    PubMed 24562446
  • Emmert A, Straube C, Buentzel J, Roever C. Robotic versus thoracoscopic lung resection: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Sep;96(35):e7633. doi: 10.1097/MD.0000000000007633.

    PubMed 28858083
  • Ciechanowicz SJ, Ma D. Anaesthesia for oncological surgery - can it really influence cancer recurrence? Anaesthesia. 2016 Feb;71(2):127-31. doi: 10.1111/anae.13342. Epub 2015 Dec 16. No abstract available.

    PubMed 26669960
  • Kim R. Anesthetic technique and cancer recurrence in oncologic surgery: unraveling the puzzle. Cancer Metastasis Rev. 2017 Mar;36(1):159-177. doi: 10.1007/s10555-016-9647-8.

    PubMed 27866303
  • Byrne K, Levins KJ, Buggy DJ. Can anesthetic-analgesic technique during primary cancer surgery affect recurrence or metastasis? Can J Anaesth. 2016 Feb;63(2):184-92. doi: 10.1007/s12630-015-0523-8.

    PubMed 26497721
  • Mascha EJ, Yang D, Weiss S, Sessler DI. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91. doi: 10.1097/ALN.0000000000000686.

    PubMed 25929547
  • Lonjaret L, Lairez O, Minville V, Geeraerts T. Optimal perioperative management of arterial blood pressure. Integr Blood Press Control. 2014 Sep 12;7:49-59. doi: 10.2147/IBPC.S45292. eCollection 2014.

    PubMed 25278775
  • Charlson ME, MacKenzie CR, Gold JP, Ales KL, Topkins M, Shires GT. Preoperative characteristics predicting intraoperative hypotension and hypertension among hypertensives and diabetics undergoing noncardiac surgery. Ann Surg. 1990 Jul;212(1):66-81. doi: 10.1097/00000658-199007000-00010.

    PubMed 2363606
  • Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.

    PubMed 19934864
  • Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.

    PubMed 26083768
  • Scholz AF, Oldroyd C, McCarthy K, Quinn TJ, Hewitt J. Systematic review and meta-analysis of risk factors for postoperative delirium among older patients undergoing gastrointestinal surgery. Br J Surg. 2016 Jan;103(2):e21-8. doi: 10.1002/bjs.10062. Epub 2015 Dec 16.

    PubMed 26676760
  • Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

    PubMed 28973220

Questions about this trial

What is this clinical trial studying?

A study testing Dexamethasone, Targeted blood pressure management and Routine blood presure management in people with Lung Cancer and Surgery, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD, PhD (86 (10) 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival after surgery (time frame: Up to 5 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04209218, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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