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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Procedure: epidural anesthesia; Procedure: general anesthesia

• Registration Number: NCT01978717
• Lead Sponsor: Changhong Miao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-05
• Study Completion: 2012-09
• Status Verified: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Last Update Submitted: 2013-11-01
• Study First Posted: 2013-11-07
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia & epidural anesthesia	epidural anesthesia	26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery
general anesthesia & epidural anesthesia	general anesthesia	26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery
general anesthesia	general anesthesia	27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery

Primary Outcome Measures

Name	Time	Method
The changes of peripheral immune cells and cytokines	within the first 5 days after surgery	The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines

Trial Locations

Locations (1)

Zhong Shan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China