## Protocol Section
### Identification Module
**NCT ID:** NCT02136979

**Brief Title:** Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery

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

#### Organization Study ID Info
**ID:** KUH1160064
#### Organization
**Class:** OTHER
**Full Name:** Konkuk University Medical Center
### Status Module
#### Completion Date
**Date:** 2017-08-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-01-18

**Type:** ACTUAL

**Last Update Submit Date:** 2018-01-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2014-05-21

**Type:** ACTUAL

**Status Verified Date:** 2018-01

#### Study First Post Date
**Date:** 2014-05-13
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-07
**Study First Submit QC Date:** 2014-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Konkuk University Medical Center

#### Responsible Party

**Investigator Affiliation:** Konkuk University Medical Center

**Investigator Full Name:** Seong-Hyop Kim

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Valvular Heart Disease

- Aortic Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 2

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients with propofol-based anesthesia

**Intervention Names:**

- Drug: Propofol

**Label:** Propofol group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** patients with sevoflurane-based anesthesia

**Intervention Names:**

- Drug: Sevoflurane

**Label:** Sevoflurane group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Propofol group

**Description:** group of patients with propofol-based anesthesia

**Name:** Propofol

**Other Names:**

- Propofol group

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Sevoflurane group

**Description:** group of patients with sevoflurane-based anesthesia

**Name:** Sevoflurane

**Other Names:**

- Sevoflurane group

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The difference of CD39 and CD73 level between propofol and sevoflurane group

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 90 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Konkuk University Medical Center

**Zip:** 143-729

#### Overall Officials

**Official 1:**

**Affiliation:** Konkuk University Medical Center

**Name:** Seong-Hyop Kim, M.D, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: HIGH

- As Found: Valvular Heart Disease

- ID: M4334

- Name: Aortic Diseases

- Relevance: HIGH

- As Found: Aortic Diseases

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000001018

- Term: Aortic Diseases

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000018685

- Term: Anesthetics, Inhalation

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

### Intervention Browse Module - Browse Leaves

- ID: M18307

- Name: Propofol

- Relevance: HIGH

- As Found: COVID-19

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M1673

- Name: Sevoflurane

- Relevance: HIGH

- As Found: Metabolic

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20765

- Name: Anesthetics, Inhalation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000015742

- Term: Propofol

- ID: D000077149

- Term: Sevoflurane

### Misc Info Module

- Version Holder: 2024-05-24
