- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461551
Anesthesia and Lymphocytes Apoptosis (OPCAB)
May 6, 2015 updated by: Li-Jie Jia, Ruijin Hospital
Different Effects of Sevoflurane, Propofol and Combine of Sevoflurane and Propofol Maintained Anesthesia on Peripheral Blood Lymphocytes During Off-pump Coronary Artery Bypass Graft Surgery
Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
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
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Shanghai, Shanghai, China, 200025
- Ruijin Hospital
-
-
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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male adults
- aged 18-80 yr
- undergoing elective OPCAB surgery containing left anterior descending artery bypass
Exclusion Criteria:
- a previous unusual response to any of the experimental anesthetics
- severe cardiac dysrhythmias or ejection fraction below 30%
- hemodynamic instability
- previous surgical coronary artery repair
- anemia, abnormal leukocytes or coagulopathy
- severe hypertension
- severe hepatic (albumin<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
- concomitant surgical procedures and psychiatric disorders
- Insulin-dependent diabetics
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Sevoflurane
|
anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
|
|
EXPERIMENTAL: Propofol
|
anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
|
|
EXPERIMENTAL: Combine of sevoflurane and propofol
|
anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0
minimum alveolar concentration)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lymphocyte Count
Time Frame: 1 day after surgery
|
Blood samples were obtained 24 h after the surgery for routine blood examination.
This analysis was performed in the hospital laboratory using routine laboratory procedures.
|
1 day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intensive Care Unit Staying Days
Time Frame: participants will stay in intensive care unit after surgery, an expected average of 2 days
|
participants will stay in intensive care unit after surgery, an expected average of 2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bu-Wei Yu, Ph.D., M.D., Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine
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.
Helpful Links
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
October 1, 2011
Primary Completion (ACTUAL)
February 1, 2012
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
October 19, 2011
First Submitted That Met QC Criteria
October 26, 2011
First Posted (ESTIMATE)
October 28, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPCAB
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.