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Epidural Anesthesia and Long-term Outcomes in Elderly Patients After Surgery

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ClinicalTrials.gov Identifier: NCT03335826
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : April 14, 2020
Sponsor:
Collaborators:
Peking University People's Hospital
Peking University Third Hospital
Beijing Hospital
Beijing Shijitan Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Elderly Patients Solid Organ Cancer Surgical Resection Epidural Anesthesia Long-term Outcome Procedure: Combined epidural-general anesthesia Procedure: General anesthesia Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1802 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Epidural Anesthesia-analgesia on Long-term Outcomes in Elderly Patients After Surgery: 5-year Follow-up of a Multicenter Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined epidural-general anesthesia
Patients assigned to this group receive combined epidural-general anesthesia and postoperative patient-controlled epidural analgesia.
Procedure: Combined epidural-general anesthesia
Combined epidural-general anesthesia and postoperative epidural analgesia.

Active Comparator: General anesthesia
Patients assigned to this group receive general anesthesia and postoperative patient-controlled intravenous analgesia.
Procedure: General anesthesia
General anesthesia and postoperative intravenous analgesia.




Primary Outcome Measures :
  1. Overall survival after surgery. [ Time Frame: Up to median 5 years after surgery. ]
    Time from surgery to the date of all-cause death.


Secondary Outcome Measures :
  1. Cancer-specific survival after surgery. [ 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.

  2. Recurrence-free survival after surgery. [ 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.

  3. Event-free survival after surgery. [ 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.


Other Outcome Measures:
  1. Overall survival after surgery (cancer patients). [ Time Frame: Up to median 5 years after surgery. ]
    Time from surgery to the date of all-cause death.

  2. Cancer-specific survival after surgery (cancer patients). [ 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.

  3. Recurrence-free survival after surgery (cancer patients). [ 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.

  4. Event-free survival after surgery (cancer patients). [ 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.

  5. Cognitive function (3-year survivors). [ 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).

  6. Quality of life (3-year survivors). [ 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).



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Refused 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 were considered unsuitable for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335826


Locations
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China, Beijing
Beijing University First Hospital
Beijing, Beijing, China, 100034
China
Beijing Shijitan Hospital
Beijing, China, 100038
Peking University People's Hospital
Beijing, China, 100044
Peking University Third Hospital
Beijing, China, 100191
Beijing Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking University First Hospital
Peking University People's Hospital
Peking University Third Hospital
Beijing Hospital
Beijing Shijitan Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD, PHD Peking University First Hospital
Publications:

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Responsible Party: Dong-Xin Wang, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03335826    
Other Study ID Numbers: PUCRP201101-2
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will ba available on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Elderly
Cancer surgery
Epidural anesthesia and analgesia
Long-term survival
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs