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Clinical Trials/NCT05136508
NCT05136508CompletedNot 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 enrollmentStarted: May 21, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Changes in blood concentration of syndecan-1

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Experimental

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 (Drug)

Inhalation

Active Comparator

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 (Drug)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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