General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
epidural anesthesia
general anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Anesthesia, T-helper, MDSCs, Colorectal cancer, Fast track
Eligibility Criteria
Inclusion Criteria:
- patients with Colorectal Cancer(CRC);
- subjected to the Fast-Track processing of surgery;
- between 18 and 75 years old.
Exclusion Criteria:
- American Society of Anesthesiologists(ASA) grade > III;
- BMI > 30;
- a history of abdominal surgery, endocrine or immune system dysfunction;
- recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
- previous contraindication to epidural anesthesia.
Sites / Locations
- Zhong Shan Hospital Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
general anesthesia & epidural anesthesia
general anesthesia
Arm Description
26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery
27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery
Outcomes
Primary Outcome Measures
The changes of peripheral immune cells and cytokines
The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01978717
Brief Title
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Changhong Miao
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Anesthesia, T-helper, MDSCs, Colorectal cancer, Fast track
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
general anesthesia & epidural anesthesia
Arm Type
Experimental
Arm Description
26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery
Arm Title
general anesthesia
Arm Type
Experimental
Arm Description
27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery
Intervention Type
Procedure
Intervention Name(s)
epidural anesthesia
Intervention Type
Procedure
Intervention Name(s)
general anesthesia
Intervention Description
Patients received general anesthesia for surgery
Primary Outcome Measure Information:
Title
The changes of peripheral immune cells and cytokines
Description
The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines
Time Frame
within the first 5 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with Colorectal Cancer(CRC);
subjected to the Fast-Track processing of surgery;
between 18 and 75 years old.
Exclusion Criteria:
American Society of Anesthesiologists(ASA) grade > III;
BMI > 30;
a history of abdominal surgery, endocrine or immune system dysfunction;
recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
previous contraindication to epidural anesthesia.
Facility Information:
Facility Name
Zhong Shan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23437162
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.
Results Reference
background
Learn more about this trial
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
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