NCT05049278

Effects of Vasopressor on the Graft Blood Flow in TRAM

Effects of Norepinephrine vs. Phenylephrine on the Graft Blood Flow Measured by Transit Time Flowmetry in Breast Reconstruction With Free Flap Transfer Surgery: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2021-09-24
• Primary completion: 2022-02-23
• Completion: 2023-02-23
• First posted: 2021-09-20
• Last updated: 2023-05-03

Locations

1 site across 1 country: South Korea