Neoplasms Clinical Trial
Official title:
Impact of Inhalational Versus Intravenous Anesthesia Maintenance Methods on 5-year Survival in Elderly Patients After Cancer Surgery: a Randomized Controlled Trial
Verified date | April 2022 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgery is one of the major treatment methods for patients with solid organ cancer. And, alone with the ageing process, more and more elderly patients undergo surgery for cancer. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. From the point of view of immune function after surgery and invasiveness of malignant tumor cells, propofol intravenous anesthesia may be superior to inhalational anesthesia. However, the clinical significance of these effects remains unclear. Retrospective studies indicated that use of propofol intravenous anesthesia was associated higher long-term survival rate. Prospective studies exploring the effect of anesthetic choice on long-term survival in cancer surgery patients are urgently needed.
Status | Active, not recruiting |
Enrollment | 1228 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | Inclusion Criteria: - Participants will be included if they meet all the following criteria: 1. Age = 65 years and < 90 years; 2. Primary malignant tumor; 3. Do not receive radiation therapy or chemotherapy before surgery; 4. Scheduled to undergo surgery for the treatment of tumors, with an expected duration of 2 hours or more, under general anesthesia; 5. Agree to participate, and give signed written informed consent. Exclusion Criteria: - Patients will be excluded if they meet any of the following criteria: 1. Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis; 2. Inability to communicate in the preoperative period (coma, profound dementia, language barrier, or end-stage disease); 3. Critical illness (preoperative American Society of Anesthesiologists physical status classification = IV); 4. Severe hepatic dysfunction (Child-Pugh class C), or severe renal dysfunction (undergoing dialysis before surgery); 5. Neurosurgery. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Shijitan Hospital | Beijing | Beijing |
China | Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital | Beijing | Beijing |
China | Peking University Cancer Hospital | Beijing | Beijing |
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
China | Guizhou Provincial People's Hospital | Guiyang | Guizhou |
China | Zhongda Hospital | Nanjing | Jiangsu |
China | Cancer Hospital of Guangxi Medical University | Nanning | Guangxi |
China | Hebei Medical University Forth Hospital | Shijiazhuang | Hebei |
China | Shaanxi Provincial People's Hospital | Taiyuan | Shanxi |
China | Shanxi Province Cancer Hospital | Taiyuan | Shanxi |
China | Tianjin Nankai Hospital | Tianjin | |
China | Tang-Du Hospital | Xi'an | Shaanxi |
China | Affiliated Hospital of Qinghai University | Xining | Qinghai |
China | Ningxia People's Hospital | Yinchuan | Ningxia |
China | The First Affiliated Hospital of Zhengzhou University | Zhenzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9. — View Citation
Deegan CA, Murray D, Doran P, Moriarty DC, Sessler DI, Mascha E, Kavanagh BP, Buggy DJ. Anesthetic technique and the cytokine and matrix metalloproteinase response to primary breast cancer surgery. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):490-5. doi: 10.1097/AAP.0b013e3181ef4d05. — View Citation
Desmond F, McCormack J, Mulligan N, Stokes M, Buggy DJ. Effect of anaesthetic technique on immune cell infiltration in breast cancer: a follow-up pilot analysis of a prospective, randomised, investigator-masked study. Anticancer Res. 2015 Mar;35(3):1311-9. — View Citation
Ecimovic P, Murray D, Doran P, Buggy DJ. Propofol and bupivacaine in breast cancer cell function in vitro - role of the NET1 gene. Anticancer Res. 2014 Mar;34(3):1321-31. — View Citation
Enlund M, Berglund A, Andreasson K, Cicek C, Enlund A, Bergkvist L. The choice of anaesthetic--sevoflurane or propofol--and outcome from cancer surgery: a retrospective analysis. Ups J Med Sci. 2014 Aug;119(3):251-61. doi: 10.3109/03009734.2014.922649. Epub 2014 May 26. — View Citation
Huang H, Benzonana LL, Zhao H, Watts HR, Perry NJ, Bevan C, Brown R, Ma D. Prostate cancer cell malignancy via modulation of HIF-1a pathway with isoflurane and propofol alone and in combination. Br J Cancer. 2014 Sep 23;111(7):1338-49. doi: 10.1038/bjc.2014.426. Epub 2014 Jul 29. — View Citation
Liang H, Gu M, Yang C, Wang H, Wen X, Zhou Q. Sevoflurane inhibits invasion and migration of lung cancer cells by inactivating the p38 MAPK signaling pathway. J Anesth. 2012 Jun;26(3):381-92. doi: 10.1007/s00540-011-1317-y. Epub 2012 Feb 17. — View Citation
Liang H, Yang CX, Zhang B, Wang HB, Liu HZ, Lai XH, Liao MJ, Zhang T. Sevoflurane suppresses hypoxia-induced growth and metastasis of lung cancer cells via inhibiting hypoxia-inducible factor-1a. J Anesth. 2015 Dec;29(6):821-30. doi: 10.1007/s00540-015-2035-7. Epub 2015 May 23. — View Citation
Margarit SC, Vasian HN, Balla E, Vesa S, Ionescu DC. The influence of total intravenous anaesthesia and isoflurane anaesthesia on plasma interleukin-6 and interleukin-10 concentrations after colorectal surgery for cancer: a randomised controlled trial. Eur J Anaesthesiol. 2014 Dec;31(12):678-84. doi: 10.1097/EJA.0000000000000057. — View Citation
Miao Y, Zhang Y, Wan H, Chen L, Wang F. GABA-receptor agonist, propofol inhibits invasion of colon carcinoma cells. Biomed Pharmacother. 2010 Nov;64(9):583-8. doi: 10.1016/j.biopha.2010.03.006. Epub 2010 May 4. — View Citation
Müller-Edenborn B, Roth-Z'graggen B, Bartnicka K, Borgeat A, Hoos A, Borsig L, Beck-Schimmer B. Volatile anesthetics reduce invasion of colorectal cancer cells through down-regulation of matrix metalloproteinase-9. Anesthesiology. 2012 Aug;117(2):293-301. doi: 10.1097/ALN.0b013e3182605df1. — View Citation
Ren XF, Li WZ, Meng FY, Lin CF. Differential effects of propofol and isoflurane on the activation of T-helper cells in lung cancer patients. Anaesthesia. 2010 May;65(5):478-82. doi: 10.1111/j.1365-2044.2010.06304.x. Epub 2010 Mar 19. — View Citation
Wang P, Chen J, Mu LH, Du QH, Niu XH, Zhang MY. Propofol inhibits invasion and enhances paclitaxel- induced apoptosis in ovarian cancer cells through the suppression of the transcription factor slug. Eur Rev Med Pharmacol Sci. 2013 Jul;17(13):1722-9. Erratum in: Eur Rev Med Pharmacol Sci. 2021 Nov;25(21):6446. — View Citation
Wei GH, Zhang J, Liao DQ, Li Z, Yang J, Luo NF, Gu Y. The common anesthetic, sevoflurane, induces apoptosis in A549 lung alveolar epithelial cells. Mol Med Rep. 2014 Jan;9(1):197-203. doi: 10.3892/mmr.2013.1806. Epub 2013 Nov 18. — View Citation
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Wigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016 Jan;124(1):69-79. doi: 10.1097/ALN.0000000000000936. — View Citation
Zhang T, Fan Y, Liu K, Wang Y. Effects of different general anaesthetic techniques on immune responses in patients undergoing surgery for tongue cancer. Anaesth Intensive Care. 2014 Mar;42(2):220-7. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Over survival after surgery. | Time from surgery to the date of all-cause death. | Up to 5 years after surgery | |
Secondary | Recurrence-free survival after surgery | Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever occurs first. | Up to 5 years after surgery | |
Secondary | Event-free survival after surgery | Time from surgery to the date of cancer recurrence/metastasis, new cancer, new serious non-cancer disease (required rehospitalization), or all-cause death, whichever occurs first. | Up to 5 years after surgery |
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