Clinical trial · Interventional
Epidural Anesthesia-analgesia and Long-term Outcome
Impact of Epidural Anesthesia-analgesia on Long-term Outcome in Elderly Patients After Surgery: 5-year Follow-up of a Multicenter Randomized Controlled Trial
NCT03012945CI-TRIAL-00045853completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Elderly | — | UNRESOLVED | — |
| Epidural Anesthesia | — | UNRESOLVED | — |
| Long-term Outcome | — | UNRESOLVED | — |
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
| Surgical Resection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined epidural-general anesthesia | Drug | — | UNRESOLVED |
| General anesthesia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combined epidural-general anesthesia
- description
- Patients assigned to this group (experimental group) receive combined epidural-general anesthesia and postoperative patient-controlled epidural analgesia.
- interventionNames
- Drug: Combined epidural-general anesthesia
- type
- ACTIVE_COMPARATOR
- label
- General anesthesia
- description
- Patients assigned to this group (control group) receive general anesthesia and postoperative patient-controlled intravenous analgesia.
- interventionNames
- Drug: General anesthesia
Primary outcomes (1)
- measure
- Overall survival after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (13)
- BACKGROUNDYamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009. PMID 10862196
- BACKGROUNDShakhar 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. doi: 10.1245/aso.2003.02.007. PMID 14527919
- BACKGROUNDSessler DI. Long-term consequences of anesthetic management. Anesthesiology. 2009 Jul;111(1):1-4. doi: 10.1097/ALN.0b013e3181a913e1. No abstract available. PMID 19512884
- BACKGROUNDBuggy DJ, Smith G. Epidural anaesthesia and analgesia: better outcome after major surgery?. Growing evidence suggests so. BMJ. 1999 Aug 28;319(7209):530-1. doi: 10.1136/bmj.319.7209.530. No abstract available. PMID 10463878
- BACKGROUNDMelamed 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):1331-1339. doi: 10.1213/01.ANE.0000082995.44040.07. PMID 14570648
- BACKGROUNDMitsuhata 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. doi: 10.1016/0192-0561(95)00026-x. PMID 7499031
- BACKGROUNDMarkovic 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. doi: 10.1097/00000542-199304000-00013.