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Clinical Trials/NCT05136508
NCT05136508
Completed
Not Applicable

The Effect of Volatile Anesthesia and Total Intravenous Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Mastectomy and Breast Reconstruction Using Deep Inferior Epigastric Artery Perforator Free Flap

Yonsei University1 site in 1 country50 target enrollmentMay 21, 2021

Overview

Phase
Not Applicable
Intervention
Propofol
Conditions
Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction
Sponsor
Yonsei University
Enrollment
50
Locations
1
Primary Endpoint
Changes in blood concentration of syndecan-1
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and breast reconstruction using deep inferior epigastric artery perforator free flap

Detailed Description

The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and breast reconstruction using deep inferior epigastric artery perforator free flap

Registry
clinicaltrials.gov
Start Date
May 21, 2021
End Date
November 13, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients over 20 years old with ASA class I-III
  • Scheduled total mastectomy and deep inferior epigastric artery perforator flap breast reconstruction

Exclusion Criteria

  • emergency surgery
  • Bilateral deep inferior epigastric artery perforator flap breast reconstruction
  • patients unable to make their own decisions, illiterate, foreigners
  • Allergy / hypersensitivity to sevoflurane or propofol 5, Current or past history or thrombosis / thromboembolism
  • patients who are taking oral contraceptives
  • Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
  • Patients receiving anticoagulants
  • pregnant and lactating women
  • Patients with history of psychiatric disease or neurological disease

Arms & Interventions

TIVA

In the TIVA group, anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). Anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI of 25-50.

Intervention: Propofol

Inhalation

In the volatile group, anesthesia was induced with an intravenous bolus of propofol 1.0-1.5 mg/kg and TCI of remifentanil (effect-site concentration \[Ce\] of 4.0 ng/ml). Anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration) and TCI of remifentanil

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Changes in blood concentration of syndecan-1

Time Frame: 1) 10 minutes after anesthesia induction <before surgery(base concentration)> 2) 10 minutes after sitting position 3) 1 hour after surgery

Blood levels of syndecan-1 are assessed at 10 minutes after anesthesia induction, 10 minutes after sitting position, and 1 hour after surgery.

Study Sites (1)

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