Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anesthesia and Lymphocytes Apoptosis (OPCAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461551
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : November 20, 2014
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Li-Jie Jia, Ruijin Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Sevoflurane Drug: Propofol Drug: combine of sevoflurane and propofol Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : October 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Sevoflurane Drug: Sevoflurane
anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
Experimental: Propofol Drug: Propofol
anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
Experimental: Combine of sevoflurane and propofol Drug: 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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intensive Care Unit Staying Days [ Time Frame: participants will stay in intensive care unit after surgery, an expected average of 2 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461551


Locations
Layout table for location information
China, Shanghai
Ruijin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Study Director: Bu-Wei Yu, Ph.D., M.D. Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Li-Jie Jia, resident, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01461551    
Other Study ID Numbers: OPCAB
First Posted: October 28, 2011    Key Record Dates
Results First Posted: November 20, 2014
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Li-Jie Jia, Ruijin Hospital:
troponin I
creatine kinase mb
hospital days
lymphocyte apoptosis
intensive care unit days
Additional relevant MeSH terms:
Layout table for MeSH terms
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation