- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978717
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
-
-
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
|
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
|
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
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.
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
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
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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