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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02758249
Other study ID # KUH1160098
Secondary ID
Status Completed
Phase N/A
First received February 26, 2016
Last updated January 23, 2018
Start date January 2016
Est. completion date January 2016

Study information

Verified date January 2018
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anesthetics agents has an effect on immune response during the cancer surgery.This influence can regulatory to immune activity or cancer cell survival.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.


Description:

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction

2. postoperative 1 hours

3. postoperative 24 hours

Immune cells isolation from patients peripheral blood mononuclear cells. Next, immune cell were co-culture with human cancer cell line (MCF-7) for 24 hours. investigation for immune cell or cancer cell survival by flow cytometry.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patient who was planned to undergo breast cancer surgery.

Exclusion Criteria:

- age < 20 years old

- history of hypersensitivity reaction in propofol or sevoflurane

- history of previous cancer

- patient with ongoing inflammation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
patients are anesthetized by using sevoflurane inhalation
propofol
patients are anesthetized by using propofol infusion

Locations

Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary immune cell (NK cell and CD8+ T cell) Patients blood sample are collect up to 24 hours postoperatively. These blood sample are collect in EDTA tube for NK cell and CD8+ T cell isolation from peripheral blood mononuclear cells (PBMCs). Isolation for NK cell, Ab stain with CD16 and CD56. Also, isolation for CD8+ T cell, Ab stain with CD8, that are purified from PBMCs, using FACSAria according to the manufacturer's protocol. These cell are culture with MCF-7 cancer cell line for 24 hours. After 24h, the degree of apoptosis of NK cell and CD8+ T cell was determined by flow cytometry. Suspension cell is NK cell or CD8+ T cell, these cells were harvest and washed with cell staining buffer. After washing, cell resuspended with Annexin-V binding buffer and stained with FITC-Annexin-V according to the manufacturer's protocol with analysis up to 24 hours
Secondary cancer cell (MCF-7) apoptosis Patients blood sample are collect before and 1h after anesthesia induction and at 24h postoperatively. These blood sample are collect in EDTA tube for NK cell and CD8+ T cell isolation from peripheral blood mononuclear cells (PBMCs). Isolation for NK cell, Ab stain with CD16 and CD56. Also, isolation for CD8+ T cell, Ab stain with CD8, that are purified from PBMCs, using FACSAria according to the manufacturer's protocol. These cell are culture with MCF-7 cancer cell line for 24 hours. After 24h, the degree of apoptosis of cancer cell was determined by flow cytometry. Adherent cell is cancer cell, these cells were harvest and washed with cell staining buffer. After washing, cell resuspended with Annexin-V binding buffer and stained with FITC-Annexin-V according to the manufacturer's protocol with analysis Baseline. postoperative 1 hours and 24 hours
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