Effects of Vasopressor on the Graft Blood Flow in TRAM

• Status: Not yet recruiting
• Trial end date: 2022-08-23
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Norepinephrine; Oxymetazoline; Phenylephrine

Criteria

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