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Effects of Vasopressor on the Graft Blood Flow in TRAM

NCT05049278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-03

No results posted yet for this study

Summary

The purpose of this pilot study is to investigate whether two major vasopressors (norepinephrine vs. phenylephrine) used for treatment of hypotension during breast reconstruction with free flap transfer surgery have different effects on blood flow of the flap vessel measured by transit time flowmetry. Since there are few prior studies that compared the effects of these two vasopressors on the blood flow of the flap, this study will be conducted in the form of a pilot study in order to establish the evidence for the future randomized controlled trial.

Conditions

  • Blood Flow
  • Anastomotic Failure of Flap
  • Flap Necrosis
  • Flap Ischemia

Interventions

DRUG

Norepinephrine

* Continuous drug: norepinephrine 4mg \* 1@ + D5W 200 mL (20 μg/mL) * Range: 0.03 \~ 0.09 μg/kg/min (= 0.1 \~ 0.3 mL/kg/h)

DRUG

Phenylephrine

* Continuous drug: phenylephrine 10mg \* 5@ + D5W 200 mL (250 μg/mL) * Range: 0.42 \~ 1.26 μg/kg/min (= 0.1 \~ 0.3 mL/kg/h)

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2022-02-23
Completion
2023-02-23

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05049278 on ClinicalTrials.gov