Combined epidural-general anesthesia
ProcedureCombined epidural-general anesthesia and postoperative epidural analgesia.
NCT Number: NCT03335826
Surgical resection is one of the most important treatments for solid organ cancer. Whereas cancer recurrence and/or metastasis are the major reasons of treatment failure. The outcomes after surgery are mainly dependent on the balance between the immune function of the body and the invasiveness of residual cancer. Preclinical and retrospective studies suggest that anaesthetic techniques and drugs may affect the long-term outcomes in patients undergoing cancer surgery. The investigators hypothesize that epidural anesthesia-analgesia may improve long-term survival in the elderly who undergo major surgery for cancer.
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Notify Me60 year–90 year
All sexes
Interventional
Not applicable
Beijing University First Hospital, Beijing, Beijing Municipality, China
Surgical resection is the main treatment for potentially curable solid organ cancer. However, long-term survival after cancer surgery is far from satisfactory. Quite a number of patients develop tumor metastasis and/or recurrence after surgery, which are associated with poor long-term outcomes. The development of tumor recurrence and/or metastasis after surgery is mostly dependent on the balance between the anti-tumor immune function of the body and the ability of implantation, proliferation and neovascularization of the residual cancer cells.
Studies showed that anaesthetic techniques and drugs may influence the cellular immune function and long-term outcomes. For example, it was found that ketamine and thiopental, but not propofol, suppresses natural killer (NK) cell activity; all three drugs caused a significant reduction in NK cell number; isoflurane and halothane inhibit interferon stimulation of NK cell cytotoxicity; nitrous oxide interferes with deoxyribonucleic acid, purine, and thymidylate synthesis and depresses neutrophil chemotaxis; opioids have been shown to suppress cell-mediated and humoral immunity.
Considering the potential harmful effects of general anesthesia/anesthetics, there is increasing interest on the effect of regional anaesthesia. Retrospective studies investigating the relationship between epidural anesthesia and outcomes after cancer surgery provide different results. In a meta-analysis of retrospective studies, regional anesthesia was associated with improved survival, but had no effect on the occurrence of cancer recurrence/metastasis. The investigators hypothesize that epidural anesthesia may produce favorable effects on long-term survival in the elderly who undergo major surgery for cancer under general anesthesia. However, there are no sufficient evidences in this aspect.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Combined epidural-general anesthesia and postoperative epidural analgesia.
General anesthesia and postoperative intravenous analgesia.
Time frame: Up to median 5 years after surgery.
Time from surgery to the date of all-cause death.
Time frame: Up to median 5 years after surgery.
Time from surgery to the date of cancer-specific death. Patients who die from other causes being censored at the time of death.
Time frame: Up to median 5 years after surgery.
Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever comes first.
Time frame: Up to median 5 years 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.
Time frame: Up to median 5 years after surgery.
Time from surgery to the date of all-cause death.
Time frame: Up to median 5 years after surgery.
Time from surgery to the date of cancer-specific death. Patients who die from other causes being censored at the time of death.
Time frame: Up to median 5 years after surgery.
Time from surgery to the date of cancer recurrence/metastasis or all-cause death, whichever comes first.
Time frame: Up to median 5 years 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.
Time frame: At the end of the 3rd year after surgery.
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).
Time frame: At the end of the 3rd year after surgery.
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).
Peking University First Hospital
Other
Impact of Epidural Anesthesia-analgesia on Long-term Outcomes in Elderly Patients After Surgery: 5-year Follow-up of a Multicenter Randomized Controlled Trial
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