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CompletedNCT01461551OPCABUpdated May 22, 2015Results posted

Anesthesia and Lymphocytes Apoptosis

An interventional study of Sevoflurane and Propofol in Anesthesia, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-22.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
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Study 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.

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Conditions studied

  • Anesthesia

Keywords

  • troponin I
  • creatine kinase mb
  • hospital days
  • lymphocyte apoptosis
  • intensive care unit days
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In context

Lead sponsor

Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male adults
  • aged 18-80 yr
  • undergoing elective OPCAB surgery containing left anterior descending artery bypass

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Sevoflurane

    Drug: Sevoflurane

  • Experimental
    Propofol

    Drug: Propofol

  • Experimental
    Combine of sevoflurane and propofol

    Drug: combine of sevoflurane and propofol

Interventions

  • anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)

  • anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)

  • Drugcombine 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)

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What researchers measure

Primary outcomes

  1. Lymphocyte Count

    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.

    Time frame: 1 day after surgery

Secondary outcomes

  1. Intensive Care Unit Staying Days

    Time frame: participants will stay in intensive care unit after surgery, an expected average of 2 days

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Results

Posted Nov 20, 2014

Participant flow

Patient recruitment took place from October 9, 2011 to January 12, 2012 in Ruijin Hospital. A total of 149 patients scheduled to undergo elective OPCABG surgery were assessed for eligibility, with 105 patients enrolled and allocated randomly.

Participant flow — Overall Study
MilestoneSevofluranePropofolCombine of Sevoflurane and Propofol
Started353535
Completed333433
Not completed212
Withdrew: Physician decision212

Outcome measures

PrimaryLymphocyte Count

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.

Time frame:
1 day after surgery
Reported as:
Mean · cells/nanoliter
Lymphocyte Count
cells/nanoliterSevofluranePropofolCombine of Sevoflurane and Propofol
Lymphocyte Count0.55 ± 0.250.73 ± 0.270.73 ± 0.31
SecondaryIntensive Care Unit Staying Days
Time frame:
participants will stay in intensive care unit after surgery, an expected average of 2 days

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sevoflurane—0/33 (0%)0/33 (0%)
Propofol—0/34 (0%)0/34 (0%)
Combine of Sevoflurane and Propofol—0/33 (0%)0/33 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)SevofluranePropofolCombine of Sevoflurane and PropofolTotal
Mean61 ± 862 ± 865 ± 963 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)SevofluranePropofolCombine of Sevoflurane and PropofolTotal
Female333433100
Male0000
Region of Enrollment
Region of Enrollment(participants)SevofluranePropofolCombine of Sevoflurane and PropofolTotal
China333433100
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Study locations

1 site
  • Ruijin Hospital
    Shanghai, Shanghai Municipality 200025, China
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References and documents

Publications

  • Jia L, Dong R, Zhang F, Wang W, Lu H, Luo Y, Xue Q, Yu B. Propofol Provides More Effective Protection for Circulating Lymphocytes Than Sevoflurane in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1172-9. doi: 10.1053/j.jvca.2015.01.008. Epub 2015 Feb 19. PubMed 26205644 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01461551
Lead sponsor
Ruijin Hospital
Responsible party
Li-Jie Jia (resident, Ruijin Hospital) — Principal investigator
First posted
Oct 28, 2011
Start date
Oct 2011
Primary completion
Feb 2012
Completion
Oct 2014
Results posted
Nov 20, 2014
Last update
May 22, 2015

Study contacts

Bu-Wei Yu, Ph.D., M.D.
study director · Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Sevoflurane · Propofol

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