Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 Unpublished data showed that intraoperative hypotension was also associated with shortened long-term survival in patients after lung cancer surgery.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Routine blood pressure management + dexamethasone | Experimental | Blood pressure is maintained according to routine practice. Dexamethasone (10 mg/2 ml) ia administered before anesthesia induction. |
|
| Targeted blood pressure management + placebo | Experimental | Blood pressure is maintained within ±10% from baseline. Placebo (normal saline 2 ml) is administered before anesthesia induction. |
|
| Targeted blood pressure management + dexamethasone | Experimental | Blood pressure is maintained within ±10% from baseline. Dexamethasone (10 mg/2 ml) is administered before anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone (10 mg/2 ml) is administered before anesthesia induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival after surgery | Recurrence-free survival after surgery | Up to 5 years after surgery |
| Cancer-specific survival after surgery | Cancer-specific survival after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival after surgery in cancer patients | Overall survival after surgery in cancer patients | Up to 5 years after surgery |
| Recurrence-free survival after surgery in cancer patients | Recurrence-free survival after surgery in cancer patients |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Xin Wang, MD, PhD | Contact | 86 (10) 83572784 | wangdongxin@hotmail.com | |
| Wen-Wen Huang, MD | Contact | 86 (10) 83572460 | hww9215@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | 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. | |
| 26808342 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 2 × 2 factorial randomized controlled trial
Not provided
Not provided
For dexamethasone administration, all participants, care providers, investigators, and outcomes assessors are masked. For blood pressure management, participants and outcome assessors are masked.
|
| Targeted blood pressure management | Other | 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 | Blood pressure is maintained according to routine practice. |
|
| Up to 5 years after surgery |
| Event-free survival after surgery | Event-free survival after surgery | Up to 5 years after surgery |
| Rate of intensive care unit (ICU) admission after surgery (sub-study) | Rate of ICU admission after surgery | During the day of surgery |
| Rate of ICU admission with endotracheal intubation after surgery (sub-study) | Rate of ICU admission with endotracheal intubation after surgery | During the day of surgery |
| Duration of mechanical ventilation in ICU after surgery (sub-study) | Duration of mechanical ventilation in ICU after surgery | Up to 30 days after surgery |
| Length of stay in ICU after surgery (sub-study) | Length of stay in ICU after surgery | Up to 30 days after surgery |
| 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). | Up to 5 days after surgery |
| 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. | Up to 30 days after surgery |
| Length of stay in hospital after surgery (sub-study) | Length of stay in hospital after surgery | Up to 30 days after surgery |
| Rate of 30-day all-cause mortality (sub-study) | Death due to any cause within 30 days after surgery | Up to 30 days after surgery |
| Up to 5 years after surgery |
| Cancer-specific survival after surgery in cancer patients | Cancer-specific survival after surgery in cancer patients | Up to 5 years after surgery |
| Event-free survival after surgery in cancer patients | Event-free survival after surgery in cancer patients | Up to 5 years after surgery |
| 30-item quality of life in 1-, 2-, and 3-year survivors | Quality of life is assessed with the 30-item Core Quality of Life Questionnaire (QLQ-C30), which assess functioning and symptom scales. The score of each scale ranges from 0 to 100, with higher score indicating better function or worse symptom. | At the end of the 1st, 2nd, and 3rd year after surgery |
| 13-item quality of life in 1-, 2-, and 3-year survivors | Quality of life is assessed with the 13-item Quality of Life Questionnaire-Lung Cancer Module (QLQ LC-13), which assess symptom scales. The score of each scale ranges from 0 to 100, with higher score indicating worse symptom. The QLQ LC-13 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. | At the end of the 1st, 2nd, and 3rd year after surgery |
| Pain score within 3 days after surgery (sub-study) | Pain score is assessed with the Numeric Rating Scale, an 11-point scale where 0=no pain and 10=the worst pain. | Up to 3 days after surgery |
| Subjective sleep quality score within 3 days after surgery (sub-study) | Subjective sleep quality is assessed with the Numeric Rating Scale, an 11-point scale where 0=the best sleep and 10=the worst sleep. | Up to 3 days after surgery |
| 26427363 | Background | 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. |
| 24562446 | Background | 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. |
| 28858083 | Background | 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. |
| 26669960 | Background | 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. |
| 27866303 | Background | 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. |
| 26497721 | Background | 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. |
| 25929547 | Background | 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. |
| 25278775 | Background | 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. |
| 2363606 | Background | 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. |
| 19934864 | Background | 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. |
| 26083768 | Background | 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. |
| 26676760 | Background | 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. |
| 28973220 | Background | 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. |
| 1867517 | Background | Younes RN, Rogatko A, Brennan MF. The influence of intraoperative hypotension and perioperative blood transfusion on disease-free survival in patients with complete resection of colorectal liver metastases. Ann Surg. 1991 Aug;214(2):107-13. doi: 10.1097/00000658-199108000-00003. |
| 23896023 | Background | Park SY, Lee JG, Kim J, Bae MK, Lee CY, Kim DJ, Chung KY. The influence of smoking intensity on the clinicopathologic features and survival of patients with surgically treated non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):480-486. doi: 10.1016/j.lungcan.2013.07.002. Epub 2013 Jul 26. |
| 27067550 | Background | Yu HC, Luo YX, Peng H, Wang XL, Yang ZH, Huang MJ, Kang L, Wang L, Wang JP. Association of perioperative blood pressure with long-term survival in rectal cancer patients. Chin J Cancer. 2016 Apr 11;35:38. doi: 10.1186/s40880-016-0100-8. |
| 24356162 | Background | Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. |
| 29806695 | Background | Bain CR, Draxler DF, Taylor R, Wallace S, Gouldthorpe O, Corcoran TB, Myles PS, L Medcalf R, Bozaoglu K. The early in-vivo effects of a single anti-emetic dose of dexamethasone on innate immune cell gene expression and activation in healthy volunteers. Anaesthesia. 2018 Aug;73(8):955-966. doi: 10.1111/anae.14306. Epub 2018 May 28. |
| 30821852 | Background | Polderman JAW, Farhang-Razi V, van Dieren S, Kranke P, DeVries JH, Hollmann MW, Preckel B, Hermanides J. Adverse side-effects of dexamethasone in surgical patients - an abridged Cochrane systematic review. Anaesthesia. 2019 Jul;74(7):929-939. doi: 10.1111/anae.14610. Epub 2019 Mar 1. |
| 27922839 | Background | Toner AJ, Ganeshanathan V, Chan MT, Ho KM, Corcoran TB. Safety of Perioperative Glucocorticoids in Elective Noncardiac Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Feb;126(2):234-248. doi: 10.1097/ALN.0000000000001466. |
| 30904834 | Background | Asehnoune K, Futier E, Feuillet F, Roquilly A; PACMAN group. PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study. BMJ Open. 2019 Mar 23;9(3):e021262. doi: 10.1136/bmjopen-2017-021262. |
| 25305092 | Background | Call TR, Pace NL, Thorup DB, Maxfield D, Chortkoff B, Christensen J, Mulvihill SJ. Factors associated with improved survival after resection of pancreatic adenocarcinoma: a multivariable model. Anesthesiology. 2015 Feb;122(2):317-24. doi: 10.1097/ALN.0000000000000489. |
| 29517574 | Background | Huang WW, Zhu WZ, Mu DL, Ji XQ, Nie XL, Li XY, Wang DX, Ma D. Perioperative Management May Improve Long-term Survival in Patients After Lung Cancer Surgery: A Retrospective Cohort Study. Anesth Analg. 2018 May;126(5):1666-1674. doi: 10.1213/ANE.0000000000002886. |
| 29221272 | Background | Xu H, Shu SH, Wang D, Chai XQ, Xie YH, Zhou WD. Goal-directed fluid restriction using stroke volume variation and cardiac index during one-lung ventilation: a randomized controlled trial. J Thorac Dis. 2017 Sep;9(9):2992-3004. doi: 10.21037/jtd.2017.08.98. |
| 29459895 | Background | Dinic VD, Stojanovic MD, Markovic D, Cvetanovic V, Vukovic AZ, Jankovic RJ. Enhanced Recovery in Thoracic Surgery: A Review. Front Med (Lausanne). 2018 Feb 5;5:14. doi: 10.3389/fmed.2018.00014. eCollection 2018. |
| 21946822 | Background | Khwannimit B, Bhurayanontachai R. Prediction of fluid responsiveness in septic shock patients: comparing stroke volume variation by FloTrac/Vigileo and automated pulse pressure variation. Eur J Anaesthesiol. 2012 Feb;29(2):64-9. doi: 10.1097/EJA.0b013e32834b7d82. |
| 27306799 | Background | Piccioni F, Bernasconi F, Tramontano GTA, Langer M. A systematic review of pulse pressure variation and stroke volume variation to predict fluid responsiveness during cardiac and thoracic surgery. J Clin Monit Comput. 2017 Aug;31(4):677-684. doi: 10.1007/s10877-016-9898-5. Epub 2016 Jun 15. |
| 20638869 | Background | Suehiro K, Okutani R. Stroke volume variation as a predictor of fluid responsiveness in patients undergoing one-lung ventilation. J Cardiothorac Vasc Anesth. 2010 Oct;24(5):772-5. doi: 10.1053/j.jvca.2010.03.014. Epub 2010 Jul 17. |
| 23917675 | Background | Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27. |
| 26658180 | Background | Loop T. Fast track in thoracic surgery and anaesthesia: update of concepts. Curr Opin Anaesthesiol. 2016 Feb;29(1):20-5. doi: 10.1097/ACO.0000000000000282. |
| 11445689 | Background | Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012. |
| 25173341 | Background | Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available. |
| 27780786 | Background | Detterbeck FC, Boffa DJ, Kim AW, Tanoue LT. The Eighth Edition Lung Cancer Stage Classification. Chest. 2017 Jan;151(1):193-203. doi: 10.1016/j.chest.2016.10.010. Epub 2016 Oct 22. |
| 23394211 | Background | Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D005938 | Glucocorticoids |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided