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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
Changhong Miao
About
Eligibility
Locations
Arms
Outcomes
Full info

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

51 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 1, 2013
Last Updated
November 1, 2013
Sponsor
Changhong Miao
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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
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General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer

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