NCT05136508

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 16, 2021

Last Update Submit

November 16, 2021

Conditions

Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction

Keywords

syndecan-1propofolvolatileanesthesiadeep inferior epigastric artery perforator flap breast reconstruction

Outcome Measures

Primary Outcomes (1)

  • Changes in blood concentration of syndecan-1

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

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

Study Arms (2)

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.

Drug: Propofol

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

Drug: Sevoflurane

Interventions

PropofolDRUG

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.

Also known as: TIVA group
TIVA
SevofluraneDRUG

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

Also known as: volatile group
Inhalation

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

PropofolSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Na Young Kim

    Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 29, 2021

Study Start

May 21, 2021

Primary Completion

November 13, 2021

Study Completion

November 13, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

KR(1)