- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02567929
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.
The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
- immediate before anesthesia induction
- postoperative 1 hours
- postoperative 24 hours
Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 143-729
- Konkuk University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient who was planned to undergo colon 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: propofol group
The patient who anesthetized by using propofol.
|
Patient will be anesthetized by using propofol infusion during operation.
Other Names:
|
Active Comparator: sevoflurane group
The patient who anesthetized by using propofol
|
Patient will be anesthetized by using sevoflurane inhalation during operation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CD39 and CD73 on circulating regualtory T cells
Time Frame: preoperative time. postoperative 1 hours and 24 hours
|
change of percentage of CD39 and CD73 (scores range from 0 to 100)
|
preoperative time. postoperative 1 hours and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating natural killer cells
Time Frame: preoperative time. postoperative 1 hours and 24 hours
|
change of percentage of circulating natural killer cell (scores range from 0 to 100)
|
preoperative time. postoperative 1 hours and 24 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating type 1 and type 17 helper T cells
Time Frame: preoperative time. postoperative 1 hours and 24 hours
|
change of percentage of helper T cell (scores range from 0 to 100)
|
preoperative time. postoperative 1 hours and 24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH1160086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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