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

NCT01978717 | Completed DMC

• 2 other identifiers: NO.2011-19708431910200
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

Anesthesia; T-helper; MDSCs; Colorectal cancer; Fast track

Outcome Measures

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

  within the first 5 days after surgery

Study Arms (2)

general anesthesia & epidural anesthesia

EXPERIMENTAL

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

general anesthesia

EXPERIMENTAL

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

Procedure: general anesthesia

Interventions

epidural anesthesia PROCEDURE

general anesthesia & epidural anesthesia

general anesthesia PROCEDURE

Patients received general anesthesia for surgery

general anesthesia; general anesthesia & epidural anesthesia

Eligibility Criteria

• Age: 51 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhong Miao: lead

Study Sites (1)

Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related 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.

  PMID: 23437162 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Anesthesia, Epidural; Anesthesia, General

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 7, 2013
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 7, 2013

Record last verified: 2013-11

Locations

CN (1)