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

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

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.

Study Overview

• Status: Completed
• Conditions: Valvular Heart Disease; Aortic Disease
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

Detailed Description

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.

1. Before operation (pre-CPB1)
2. 15 minute after successful CPB weaning (post-CPB1)
3. 3 hrs after CPB weaning (post-CPB2)
4. 24 hrs after CPB weaning (post-CPB3)
5. 48 hrs after CPB weaning (post-CPB4)

The following intraoperative exclusion criteria are applied:

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

Using blood sample, authors examined as follows

1. Flow cytometry for Th 17 and Th 1 cell.
2. Immunocytochemistry for CD39, CD73.
3. Assay for IL 1,6,10,17,IFN-γ, and TNF-α
4. patient vital sign during operation
5. 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. patients scheduled to undergo elective cardiac surgery
2. signed written informed consent agreements

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol group; patients with propofol-based anesthesia	Drug: Propofol; group of patients with propofol-based anesthesia; Other Names: Propofol group
Active Comparator: Sevoflurane group; patients with sevoflurane-based anesthesia	Drug: Sevoflurane; group of patients with sevoflurane-based anesthesia; Other Names: Sevoflurane group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of CD39 and CD73 between propofol and sevoflurane group after CPB	The difference of CD39 and CD73 level between propofol and sevoflurane group	from preoperative status up to 48 hrs after CPB weaning status

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Seong-Hyop Kim, M.D, Ph.D, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 11, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: KUH1160064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No