NCT02089178

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2014

Completed
Last Updated

March 19, 2019

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

March 12, 2014

Last Update Submit

March 15, 2019

Conditions

Breast Cancer

Keywords

total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor

Outcome Measures

Primary Outcomes (1)

  • number of NK cell

    comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity

    at 24 hour after surgery.

Study Arms (2)

intravenous

EXPERIMENTAL

the total intravenous anesthesia group

Procedure: intravenous anesthesiaDrug: propofol-remifentanil

inhalation

ACTIVE COMPARATOR

the inhalation anesthesia group

Procedure: inhalation anesthesiaDrug: sevoflurane-remifentanil

Interventions

intravenous anesthesiaPROCEDURE

total intravenous anesthesia group: propofol-remifentanil

intravenous
inhalation anesthesiaPROCEDURE

inhalation anesthesia group: sevoflurane-remifentanil

inhalation
propofol-remifentanilDRUG
intravenous
sevoflurane-remifentanilDRUG
inhalation

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, IntravenousAnesthesia, Inhalation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, General

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 17, 2014

Study Start

February 1, 2014

Primary Completion

December 30, 2014

Study Completion

December 30, 2014

Last Updated

March 19, 2019

Record last verified: 2014-12

Locations

KR(1)