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CompletedNCT01978717Updated Nov 7, 2013

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

An interventional study of epidural anesthesia and general anesthesia in Colorectal Neoplasms, sponsored by Changhong Miao. Completed at 1 site in China. Open to participants aged 51 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-07.

Sponsored by Changhong Miao · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
51 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Neoplasms

Keywords

  • Anesthesia
  • T-helper
  • MDSCs
  • Colorectal cancer
  • Fast track
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 53 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with Changhong Miao as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
51 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with Colorectal Cancer(CRC);
  • subjected to the Fast-Track processing of surgery;
  • between 18 and 75 years old.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • 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

  • Experimental
    general anesthesia

    27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery

    Procedure: general anesthesia

Interventions

  • Procedureepidural anesthesia
  • Proceduregeneral anesthesia

    Patients received general anesthesia for surgery

06

What researchers measure

Primary outcomes

  1. The changes of peripheral immune cells and cytokines

    The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines

    Time frame: within the first 5 days after surgery

07

Study locations

1 site
  • Zhong Shan Hospital Fudan University
    Shanghai, Shanghai 200032, China
08

References and documents

Publications

  • 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. PubMed 23437162 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01978717
Lead sponsor
Changhong Miao
Responsible party
Changhong Miao (Professor, Department of Anesthesiology, Fudan University) — Sponsor-investigator
First posted
Nov 7, 2013
Start date
Sep 2011
Primary completion
May 2012
Completion
Sep 2012
Last update
Nov 7, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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