Not Yet RecruitingPhase 4ACTRN12611000301965

Immunomodulatory effect of anaesthetic technique in breast cancer surgery

Comparison of T-lymphocyte function between propofol-remifentanil and sevoflurane anaesthesia in the breast cancer surgery

Sponsor

Jie Ae Kim

Enrollment

60 participants

Start Date

Mar 28, 2011

Study Type

Interventional

Conditions

partial mastectomy with sentinel lymph node dissection

Summary

This study will compare T-lymphocyte function including regulatory T cell subset (CD4/CD25/FoxP3) and activated T cell panel (CD4/CD8/CD69/CTLA4) and postoperative pain score and complications between propofol-remifentail and sevoflurane anaesthesia in patients undergoing partial mastectomy with sentinel lymph node dissection due to breast cancer. Sixty ASA 1-2 patients undergoing elective parial mastectomy with sentinel lymph node dissection will be randomly assigned into propofol-remifentanil or sevoflurane anaesthesia. Anaesthetic depth will be monitored with BIS with target ranges between 30-60. Blood pressure and heart rate will be maintained within 20 % of preoperative values. The administered vaso-active drugs will be recorded. Peripheral venous blood will be obtained before anaesthetic induction, before discharge from the post anaesthesia care unit, and 24 hour after end of operation and will be analyzed for regulated T-cell subset (CD4/CD25/FoxP3) and activated T cell panel(CD4/CD8/CD69/CTLA4). Postoperative pain scale score (0-10) and complications will be also evaluated.

Eligibility

Sex: FemalesMin Age: 30 YearssMax Age: 60 Yearss

Inclusion Criteria1

American society of anesthesiologists physical status (ASA) I or II and scheduled for partial mastectomy with sentinel lymph node dissection due to breast cancer

Exclusion Criteria1

elevated white blood cell count, eleveted body temperature, elevated c-reactive protein, liver cirrhosis, uncontrolled DM, uncontrolled HT, medication with steroid or non-steroidal anti-inflammatory drug

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Interventions

general anaesthesia with propofol 3 microg/ml, remifentanil 2 ng/ml in air (1 L/min) delivered at the same time with oxygen (1L/min) mixture and continuously maintained with propofol 3 microg/ml, rem

general anaesthesia with propofol 3 microg/ml, remifentanil 2 ng/ml in air (1 L/min) delivered at the same time with oxygen (1L/min) mixture and continuously maintained with propofol 3 microg/ml, remifentanil 2 ng/ml in air (1 L/min) delivered at the same time with oxygen (1L/ min) mixture during operation (approximately 90-120 minutes)

Locations(1)

Korea, Republic Of

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ACTRN12611000301965