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

NCT ID: NCT02089178

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intravenous

the total intravenous anesthesia group

Group Type EXPERIMENTAL

intravenous anesthesia

Intervention Type PROCEDURE

total intravenous anesthesia group: propofol-remifentanil

propofol-remifentanil

Intervention Type DRUG

inhalation

the inhalation anesthesia group

Group Type ACTIVE_COMPARATOR

inhalation anesthesia

Intervention Type PROCEDURE

inhalation anesthesia group: sevoflurane-remifentanil

sevoflurane-remifentanil

Intervention Type DRUG

Interventions

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intravenous anesthesia

total intravenous anesthesia group: propofol-remifentanil

Intervention Type PROCEDURE

inhalation anesthesia

inhalation anesthesia group: sevoflurane-remifentanil

Intervention Type PROCEDURE

propofol-remifentanil

Intervention Type DRUG

sevoflurane-remifentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2013-0937

Identifier Type: -

Identifier Source: org_study_id

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