Comparison of the Effect of Total Intravenous Anesthesia and Inhalation Anesthesia on Cancer Cell Cytotoxicity, Micrometastasis and Recurrence of Tumor in Patients Undergoing Breast Tumor Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02089178
Recruitment Status : Unknown
Verified March 2014 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The purpose of this study is to compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: intravenous anesthesia Procedure: inhalation anesthesia Drug: propofol-remifentanil Drug: sevoflurane-remifentanil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: intravenous
the total intravenous anesthesia group
Procedure: intravenous anesthesia
total intravenous anesthesia group: propofol-remifentanil
Drug: propofol-remifentanil
Active Comparator: inhalation
the inhalation anesthesia group
Procedure: inhalation anesthesia
inhalation anesthesia group: sevoflurane-remifentanil
Drug: sevoflurane-remifentanil

Primary Outcome Measures :
  1. number of NK cell [ Time Frame: at 24 hour after surgery. ]
    comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
  • breast cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
  • surgery performed by the same surgical team

Exclusion Criteria:

  • ASA physical status Ⅳ
  • hepatic and renal impairment
  • diabetes or other endocrine disorders
  • body mass index > 35 kg/m2
  • immune disorders or immunosuppressive therapy
  • steroid treatment in the last 6 months
  • inflammation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02089178

Contact: Bon Nyeo Koo, MD 82-2-2228-2420

Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bon Nyeo Koo, MD    82-2-2228-2420   
Principal Investigator: Bon Nyeo Koo, MD         
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT02089178     History of Changes
Other Study ID Numbers: 4-2013-0937
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by Yonsei University:
total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation