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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
* 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)
* 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)
Seoul National University Hospital
Seoul, South Korea
Graft mean blood flow measured using transit time flowmetry
Mean blood flow (in mL/min) of the graft vessel that was measured using transit time flowmetry
Time frame: Intraoperative period
Pulsatility of graft vessel measured using transit time flowmetry
Pulsatility of graft vessel, which is presented as pulsatility index in unitless, that was measured using transit time flowmetry
Time frame: Intraoperative period
Diastolic filling of the graft vessel measured using transit time flowmetry
Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry
Time frame: Intraoperative period
Graft failure rate in patients received each vasopressor during surgery
The rate of graft failure in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Capillary filling time in patients received each vasopressor during surgery
Capillary filling time, which was measured by time to refill the capillary after compression, to evaluate the viability of the flap in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Skin necrosis rate in patients received each vasopressor during surgery
The rate of skin necrosis, which is evaluated by any changes in skin color by description of the color of the skin by clinicians, to evaluate the viability of the graft in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Rate of vascular thrombosis in patients received each vasopressor during surgery
The rate of arterial or venous complication by measure of skin color change or decrease in doppler flow or capillary refill to evaluate the viability of the graft in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Rate of wound infection or any wound problem in patients received each vasopressor during surgery
The rate of any wound complication including infection to evaluate wound complication after surgery in patients each vasopressor during surgery
Time frame: Within seven days after surgery
Amount of transfusion in patients received each vasopressor during surgery
Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Total amount of remifentanil infused during surgery in patients received each vasopressor
The total amount of remifentanil infused during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
Time frame: intraoperative period
Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor
The total amount of inotropic agents or vasopressor during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
Time frame: intraoperative period
Stroke volume during surgery in patients received each vasopressor
Stroke volume (in mL) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Time frame: intraoperative period
Cardiac index during surgery in patients received each vasopressor
Cardiac index (in L/min/m\^2) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Time frame: intraoperative period
Stroke volume variation during surgery in patients received each vasopressor
Stroke volume variation (in percentage) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Time frame: intraoperative period
Serum lactate levels in patients received each vasopressor
Serum lactate levels (in mmol/L) to evaluate the postoperative variables and clinical outcomes in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Wound exploration rate in patients received each vasopressor during surgery
The rate of wound exploration as a measure of postoperative complication and graft failure to evaluate the flap outcome in patients received each vasopressor during surgery
Time frame: Until discharge
Reoperation rate in patients received each vasopressor during surgery
The rate of reoperation as a measure of postoperative complication and graft failure to evaluate the flap outcome in patients received each vasopressor during surgery
Time frame: Until discharge
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