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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000301965

Enrollment

Registered

2011-03-22

Start date

2011-03-28

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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, 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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results