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Completed

NCT Number: NCT02136979

Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery

CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies.

The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective cardiac surgery under cardiopulmonary bypass (CPB) after signed written informed consent agreements and prospectively participate in the present study.

All patients got a cardiac surgery under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon. Also, 6ml of blood and sample was obtained for total 5 times in consecutive order.

  • Before operation (pre-CPB1)
  • 15 minute after successful CPB weaning (post-CPB1)
  • 3 hrs after CPB weaning (post-CPB2)
  • 24 hrs after CPB weaning (post-CPB3)
  • 48 hrs after CPB weaning (post-CPB4)

The following intraoperative exclusion criteria are applied:

  • Emergency operation that could not obtain pre-CPB1 sample
  • Patients who have infectious factor before operation
  • Patients who have immunosuppressive agent for underlying disease before operation
  • Patients who have history of cancer previously
  • Patients who are younger than 19 years old

Using blood sample, authors examined as follows

  • Flow cytometry for Th 17 and Th 1 cell.
  • Immunocytochemistry for CD39, CD73.
  • Assay for IL 1,6,10,17,IFN-γ, and TNF-α
  • patient vital sign during operation
  • other laboratory tests

Statistical analyses are conducted using SPSS 20.0 (SPSS Inc., Chicago, IL, USA). CD39 and CD73 are analysed used a Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the tukey method. The comparisons of the other continuous variables are performed by paired t or Wilcoxon Signed Rank tests. Data are expressed as mean ± SD (95% confidence interval. CI) or median (25%-75%), and number of the patients. A p value less than 0.05 is considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients scheduled to undergo elective cardiac surgery
  • signed written informed consent agreements

Exclusion criteria

  • Emergency operation that could not obtain pre-CPB1 sample
  • Patients who have infectious factor before operation
  • Patients who have immunosuppressive agent for underlying disease before operation
  • Patients who have history of cancer previously
  • Patients who are younger than 19 years old

Treatment and study plan

Propofol

Drug

group of patients with propofol-based anesthesia

Other names: Propofol group

Sevoflurane

Drug

group of patients with sevoflurane-based anesthesia

Other names: Sevoflurane group

Primary outcomes

  1. The level of CD39 and CD73 between propofol and sevoflurane group after CPB

    Time frame: from preoperative status up to 48 hrs after CPB weaning status

    The difference of CD39 and CD73 level between propofol and sevoflurane group

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 13, 2014
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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