General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer

November 1, 2013 updated by: Changhong Miao
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhong Shan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: general anesthesia & epidural anesthesia
26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery
Procedure: epidural anesthesia
Procedure: general anesthesia
Patients received general anesthesia for surgery
Experimental: general anesthesia
27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery
Procedure: general anesthesia
Patients received general anesthesia for surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of peripheral immune cells and cytokines
Time Frame: within the first 5 days after surgery
The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines
within the first 5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhong Miao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.2011-197
  • 08431910200 (Other Grant/Funding Number: Shanghai Municipal Science and Technology Commission)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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