Effects of Vasopressor on the Graft Blood Flow in TRAM

Seoul National University

Status

Completed

Conditions

Anastomotic Failure of Flap

Flap Ischemia

Flap Necrosis

Blood Flow

Treatments

Drug: Norepinephrine

Drug: Phenylephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT05049278

TRAM_Vasopressor

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ASA Physical Status Classification Grade 1-3
Patients with an ECOG score of 0 or 1 when selecting a subject for the study
Patients who can provide written consent to participate in clinical trials
Patients requiring the use of vasopressor because the mean arterial pressure is not maintained more than 65 mmHg during surgery

Exclusion criteria

Patients with peripheral arterial diseases
Patients with allergic history to study drugs
If surgery on other areas is scheduled at the same time or is an emergency operation
Patients with history of previous abdominal surgery involving the flap donor site
Pregnant
If there are other major medical or psychiatric disorders that may affect treatment response
Left ventricular ejection fraction < 30% or with a history of arrhythmia that is not controlled by medication
Refuse to participate