Elderly Clinical Trial
Official title:
Impact of Epidural Anesthesia-analgesia on Long-term Outcome in Elderly Patients After Surgery: 5-year Follow-up of a Multicenter Randomized Controlled Trial
Verified date | July 2020 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgical resection is one of the most important treatments for resectable cancer; on the other hand, cancer recurrence and/or metastasis are the major reasons of treatment failure. The development of recurrence/metastasis after cancer surgery mostly depends on the balance between the immunity of human body and the capability of implantation, proliferation and neovascularization of the residual cancer. Preclinical and retrospective clinical studies suggest that anaesthetic management may affect the long-term outcomes after cancer surgery. The investigators hypothesize that use of epidural anesthesia-analgesia may improve long-term survival in elderly patients after major surgery for cancer.
Status | Completed |
Enrollment | 1802 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Elderly patients (age 60-90 years); - Scheduled to undergo noncardiac thoracic or abdominal surgery with an expected duration of 2 hours or longer. For those who undergo thoracoscopic or laparoscopic surgery, the expected length of incision must be 5 centimeters or more; - Agree to receive patient-controlled postoperative analgesia. Exclusion Criteria: - Refuse to participate; - Previous history of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier or end-stage disease; - History of myocardial infarction or stroke within 3 months before surgery; - Presence of any contraindication to epidural anesthesia and analgesia, including abnormal vertebral anatomy, previous spinal trauma or surgery, severe chronic back pain, coagulation disorder (prothrombin time or activated partial prothrombin time longer than 1.5 times of the upper normal limit, or platelet count of less than 80 * 10^9/L), local infection near the site of puncture, and severe sepsis; - Severe heart dysfunction (New York Heart Association functional classification 3 or above), severe hepatic insufficiency (Child-Pugh grade C), or severe renal insufficiency (serum creatinine of 442 umol/L or above, with or without serum potassium of 6.5 mmol/L or above, or requirement of renal replacement therapy); - Any other conditions that are considered unsuitable for study participation. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital | Beijing | |
China | Beijing Shijitan Hospital | Beijing | |
China | Peking University First Hospital | Beijing | Beijing |
China | Peking University People's Hospital | Beijing | |
China | Peking University Third Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | Beijing Hospital, Beijing Shijitan Hospital, Peking University, Peking University People's Hospital, Peking University Third Hospital |
China,
Beilin B, Martin FC, Shavit Y, Gale RP, Liebeskind JC. Suppression of natural killer cell activity by high-dose narcotic anesthesia in rats. Brain Behav Immun. 1989 Jun;3(2):129-37. — View Citation
Buggy DJ, Smith G. Epidural anaesthesia and analgesia: better outcome after major surgery?. Growing evidence suggests so. BMJ. 1999 Aug 28;319(7209):530-1. — View Citation
Chen WK, Miao CH. The effect of anesthetic technique on survival in human cancers: a meta-analysis of retrospective and prospective studies. PLoS One. 2013;8(2):e56540. doi: 10.1371/journal.pone.0056540. Epub 2013 Feb 20. — View Citation
Gaspani L, Bianchi M, Limiroli E, Panerai AE, Sacerdote P. The analgesic drug tramadol prevents the effect of surgery on natural killer cell activity and metastatic colonization in rats. J Neuroimmunol. 2002 Aug;129(1-2):18-24. — View Citation
Gupta K, Kshirsagar S, Chang L, Schwartz R, Law PY, Yee D, Hebbel RP. Morphine stimulates angiogenesis by activating proangiogenic and survival-promoting signaling and promotes breast tumor growth. Cancer Res. 2002 Aug 1;62(15):4491-8. — View Citation
Markovic SN, Knight PR, Murasko DM. Inhibition of interferon stimulation of natural killer cell activity in mice anesthetized with halothane or isoflurane. Anesthesiology. 1993 Apr;78(4):700-6. — View Citation
Melamed R, Bar-Yosef S, Shakhar G, Shakhar K, Ben-Eliyahu S. Suppression of natural killer cell activity and promotion of tumor metastasis by ketamine, thiopental, and halothane, but not by propofol: mediating mechanisms and prophylactic measures. Anesth Analg. 2003 Nov;97(5):1331-9. — View Citation
Mitsuhata H, Shimizu R, Yokoyama MM. Suppressive effects of volatile anesthetics on cytokine release in human peripheral blood mononuclear cells. Int J Immunopharmacol. 1995 Jun;17(6):529-34. — View Citation
O'Riain SC, Buggy DJ, Kerin MJ, Watson RW, Moriarty DC. Inhibition of the stress response to breast cancer surgery by regional anesthesia and analgesia does not affect vascular endothelial growth factor and prostaglandin E2. Anesth Analg. 2005 Jan;100(1):244-9. — View Citation
Sessler DI. Long-term consequences of anesthetic management. Anesthesiology. 2009 Jul;111(1):1-4. doi: 10.1097/ALN.0b013e3181a913e1. — View Citation
Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. Review. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall survival after surgery (cancer patients). | Time from surgery to the date of all-cause death. | Up to median 5 years after surgery. | |
Other | Cancer-specific survival after surgery (cancer patients). | Time from surgery to the date of cancer-specific death. Patients who die from other causes will be censored at the time of death. | Up to median 5 years after surgery. | |
Other | Recurrence-free survival after surgery (cancer patients). | Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever come first. | Up to median 5 years after surgery. | |
Other | Event-free survival after surgery (cancer patients). | Time from surgery to the first date of cancer recurrence/metastasis, new onset cancer, new serious non-cancer disease, or death from any cause. | Up to median 5 years after surgery. | |
Other | Cognitive function (3-year survivors). | Cognitive function is assessed with the modified Telephone Interview for Cognitive Status (TICS-m; a 12-item questionnaire that assesses global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function). | At the end of the 3rd year after surgery. | |
Other | Quality of life (3-year survivors). | Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that assesses the quality of life in physical, psychological, social relationship and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function). | At the end of the 3rd year after surgery. | |
Primary | Overall survival after surgery. | Time from surgery to the date of all-cause death. | Up to median 5 years after surgery. | |
Secondary | Cancer-specific survival after surgery. | Time from surgery to the date of cancer-specific death. Patients who die from other causes will be censored at the time of death. | Up to median 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 come first. | Up to median 5 years after surgery. | |
Secondary | Event-free survival after surgery. | Time from surgery to the first date of cancer recurrence/metastasis, new onset cancer, new serious non-cancer disease, or death from any cause. | Up to median 5 years after surgery. |
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