Intraoperative Blood Pressure Management and Dexamethasone in Lung Cancer Surgery

Официальное название

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

Обзор

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.

Подробное описание

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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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

Вмешательства

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

Первичные конечные точки

• Overall survival after surgery [Срок оценки: Up to 5 years after surgery]
• Incidence of organ injury and complications within 5 days after surgery (sub-study). [Срок оценки: Up to 5 days after surgery.]

Вторичные конечные точки (11)

• Recurrence-free survival after surgery [Срок оценки: Up to 5 years after surgery]
• Cancer-specific survival after surgery [Срок оценки: Up to 5 years after surgery]
• Event-free survival after surgery [Срок оценки: Up to 5 years after surgery]
• Rate of intensive care unit (ICU) admission after surgery (sub-study) [Срок оценки: During the day of surgery]
• Rate of ICU admission with endotracheal intubation after surgery (sub-study) [Срок оценки: During the day of surgery]
• Duration of mechanical ventilation in ICU after surgery (sub-study) [Срок оценки: Up to 30 days after surgery]
• Length of stay in ICU after surgery (sub-study) [Срок оценки: Up to 30 days after surgery]
• Incidence of organ injury within 5 days after surgery (sub-study) [Срок оценки: Up to 5 days after surgery]
• Incidence of complications within 30 days after surgery (sub-study) [Срок оценки: Up to 30 days after surgery]
• Length of stay in hospital after surgery (sub-study) [Срок оценки: Up to 30 days after surgery]
• Rate of 30-day all-cause mortality (sub-study) [Срок оценки: Up to 30 days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

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

Публикации

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• 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. PMID 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 PMID 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. PMID 24562446
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• 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. PMID 26669960
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Идентификаторы

NCT: NCT04209218 · 2019-234

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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