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

• Sponsor: Yonsei University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02089178
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 10.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Dec 30, 2014
• Actual Study Completion Date: Dec 30, 2014

Arms and Interventions

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

Primary Outcome Measures

1. number of NK cell [at 24 hour after surgery.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02089178
• Other Study ID Numbers: 4-2013-0937
• First Posted: Mar 17, 2014
• Last Update Posted: Mar 19, 2019
• Last Verified: Dec 1, 2014

• Keywords provided by Yonsei University: total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor
• Additional relevant MeSH terms: Breast Neoplasms; Remifentanil; Anesthetics; Propofol; Sevoflurane

Study Results

No Results Posted as of Mar 19, 2019