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

Colorectal Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978717
• Other study ID #: NO.2011-197
• Secondary ID: 08431910200
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: November 1, 2013
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Procedure:
• epidural anesthesia

• general anesthesia
Patients received general anesthesia for surgery

Locations

Country	Name	City	State
China	Zhong Shan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhong Miao

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of peripheral immune cells and cytokines	The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines	within the first 5 days after surgery	Yes