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

Not Applicable

Completed

• Conditions: Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT05136508
• Lead Sponsor: Yonsei University

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 Timeline

• Study Start: 2021-05-21
• Status Verified: 2021-11
• Primary Completion: 2021-11-13
• Study Completion: 2021-11-13
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-29
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

1. emergency surgery

2. Bilateral deep inferior epigastric artery perforator flap breast reconstruction

3. patients unable to make their own decisions, illiterate, foreigners

4. Allergy / hypersensitivity to sevoflurane or propofol 5, Current or past history or thrombosis / thromboembolism

5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalation	Sevoflurane	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
TIVA	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Changes in blood concentration of syndecan-1	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.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of