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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.
 
ClinicalTrials.gov Identifier: NCT02089178
Recruitment Status : Terminated (The study costed more than expected, so the investigators decided to end it.)
First Posted : March 17, 2014
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Study Start Date : February 2014
Actual Primary Completion Date : December 30, 2014
Actual Study Completion Date : December 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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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 ClinicalTrials.gov identifier (NCT number): NCT02089178


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02089178    
Other Study ID Numbers: 4-2013-0937
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: December 2014
Keywords provided by Yonsei University:
total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Remifentanil
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
 Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation