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

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
      • 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.

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

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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