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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02089178
First received: March 12, 2014
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Procedure: intravenous anesthesia
Procedure: inhalation anesthesia
Drug: propofol-remifentanil
Drug: sevoflurane-remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • number of NK cell [ Time Frame: at 24 hour after surgery. ] [ Designated as safety issue: No ]
    comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity


Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089178

Contacts
Contact: Bon Nyeo Koo, MD 82-2-2228-2420 koobn@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bon Nyeo Koo, MD    82-2-2228-2420    koobn@yuhs.ac   
Principal Investigator: Bon Nyeo Koo, MD         
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02089178     History of Changes
Other Study ID Numbers: 4-2013-0937
Study First Received: March 12, 2014
Last Updated: March 14, 2014
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Propofol
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014