Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000301965
Ethics application status
Approved
Date submitted
7/03/2011
Date registered
22/03/2011
Date last updated
22/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Immunomodulatory effect of anaesthetic technique in breast cancer surgery
Scientific title
Comparison of T-lymphocyte function between propofol-remifentanil and sevoflurane anaesthesia in the breast cancer surgery
Secondary ID [1] 259744 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 261328 0
partial mastectomy with sentinel lymph node dissection 261329 0
Condition category
Condition code
Cancer 259473 259473 0 0
Breast
Anaesthesiology 259474 259474 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 264175 0
Treatment: Other
Intervention code [2] 264251 0
Treatment: Drugs
Comparator / control treatment
general anaesthesia with sevoflurane 1-2 minimum alveolar concentration in air (1 L/min) delivered at the same time with oxygen (1L/min) mixture and continuously maintained with sevoflurane 1-2 minimum alveolar concentration in air (1 L/min) delivered at the same time with oxygen (1L/min) mixture during operation (approximately 90-120 minutes)
Control group
Active

Outcomes
Primary outcome [1] 262285 0
regulatory T cell subset(CD4/CD25/FoxP3) in peripheral blood will be evaluated using flow cytometry after monoclonal antibody staining
Timepoint [1] 262285 0
before anaesthetic induction, before discharge from the post anaesthesia care unit (PACU), 24 hour after end of operation
Primary outcome [2] 262286 0
activated T-cell panel (CD4/CD8/CD69/CTLA4) in peripheral blood will be evaluated using flow cytometry after monoclonal antibody staining
Timepoint [2] 262286 0
before anaesthetic induction, before discharge from the post anaesthesia care unit (PACU), 24 hour after end of operation
Secondary outcome [1] 273458 0
dose of vaso-active drugs
Timepoint [1] 273458 0
during operation
Secondary outcome [2] 273459 0
pain-scale (0-10 visual analogue scale score)
Timepoint [2] 273459 0
before discharge from the PACU, 24 hour after end of operation
Secondary outcome [3] 273460 0
dose of the pain killer drug
Timepoint [3] 273460 0
before discharge from the PACU, 24 hour after end of operation
Secondary outcome [4] 273461 0
hospital complications including wound problem and elevated temperature will be assessed clinically
Timepoint [4] 273461 0
from end of operation until discharge

Eligibility
Key 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
Minimum age
30 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3295 0
Korea, Republic Of
State/province [1] 3295 0

Funding & Sponsors
Funding source category [1] 264623 0
Hospital
Name [1] 264623 0
Samsung Medical Center Clinical Research Development Program grant, CRS110-07-1
Country [1] 264623 0
Korea, Republic Of
Primary sponsor type
Individual
Name
Jie Ae Kim
Address
50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 263761 0
Individual
Name [1] 263761 0
Eun Sook Gang
Address [1] 263761 0
50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country [1] 263761 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266628 0
Institutional review board
Ethics committee address [1] 266628 0
50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Ethics committee country [1] 266628 0
Korea, Republic Of
Date submitted for ethics approval [1] 266628 0
Approval date [1] 266628 0
01/08/2010
Ethics approval number [1] 266628 0
2009-06-009-005

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32318 0
Address 32318 0
Country 32318 0
Phone 32318 0
Fax 32318 0
Email 32318 0
Contact person for public queries
Name 15565 0
Jie Ae Kim
Address 15565 0
Department of anesthesiology and pain medicine. Samsung Medical Center, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country 15565 0
Korea, Republic Of
Phone 15565 0
82-2-3410-0363
Fax 15565 0
Email 15565 0
[email protected]
Contact person for scientific queries
Name 6493 0
Jie Ae Kim
Address 6493 0
Department of anesthesiology and pain medicine. Samsung Medical Center, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, South Korea
Country 6493 0
Korea, Republic Of
Phone 6493 0
82-2-3410-0363
Fax 6493 0
Email 6493 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.