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Completed

NCT Number: NCT05136508

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

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

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Key information

Conditions

Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 7. Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) 8. Patients receiving anticoagulants 9. pregnant and lactating women 10. Patients with history of psychiatric disease or neurological disease

Treatment and study plan

Propofol

Drug

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.

Other names: TIVA group

Sevoflurane

Drug

Anesthesia was induced with an intravenous bolus of propofol 1.5-2 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

Other names: volatile group

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2021
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.