Comparison of the Effect of Total Intravenous Anesthesia... | NCT02089178

Studies
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

NCT02089178

Sponsor

Yonsei University

Status

Terminated

Last Update Posted

Mar 19, 2019Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

intravenous anesthesia
inhalation anesthesia
propofol-remifentanil
sevoflurane-remifentanil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study costed more than expected, so the investigators decided to end it.

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 30, 2014Actual

Completion Date

Dec 30, 2014Actual

First Submitted Date

Mar 12, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2019

Last Update Posted Date

Mar 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intravenous	Experimental	the total intravenous anesthesia group	Procedure: intravenous anesthesia Drug: propofol-remifentanil
inhalation	Active Comparator	the inhalation anesthesia group	Procedure: inhalation anesthesia Drug: sevoflurane-remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravenous anesthesia	Procedure	total intravenous anesthesia group: propofol-remifentanil	intravenous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of NK cell	comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity	at 24 hour after surgery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul		120-752	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000771	Anesthesia, Intravenous
D000769	Anesthesia, Inhalation

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia
D000768	Anesthesia, General