Anastomotic Failure of Flap, Blood Flow, Flap Ischemia, Flap Necrosis
Conditions
Keywords
Blood flow, Failure of Flap, Vasopressor, Phenylephrine, Norepinephrine
Brief 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.
Interventions
DRUGNorepinephrine
* 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)
DRUGPhenylephrine
* 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
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft mean blood flow measured using transit time flowmetry | Intraoperative period | Mean blood flow (in mL/min) of the graft vessel that was measured using transit time flowmetry |
| Pulsatility of graft vessel measured using transit time flowmetry | Intraoperative period | Pulsatility of graft vessel, which is presented as pulsatility index in unitless, that was measured using transit time flowmetry |
| Diastolic filling of the graft vessel measured using transit time flowmetry | Intraoperative period | Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke volume variation during surgery in patients received each vasopressor | intraoperative period | Stroke volume variation (in percentage) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor |
| Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor | intraoperative period | The total amount of inotropic agents or vasopressor during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery |
| Graft failure rate in patients received each vasopressor during surgery | Within seven days after surgery | The rate of graft failure in patients received each vasopressor during surgery |
| Capillary filling time in patients received each vasopressor during surgery | Within seven days after 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 |
| Skin necrosis rate in patients received each vasopressor during surgery | Within seven days after 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 |
| Stroke volume during surgery in patients received each vasopressor | intraoperative period | Stroke volume (in mL) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor |
| Rate of wound infection or any wound problem in patients received each vasopressor during surgery | Within seven days after surgery | The rate of any wound complication including infection to evaluate wound complication after surgery in patients each vasopressor during surgery |
| Amount of transfusion in patients received each vasopressor during surgery | Within seven days after surgery | Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery |
| Serum lactate levels in patients received each vasopressor | Within seven days after surgery | Serum lactate levels (in mmol/L) to evaluate the postoperative variables and clinical outcomes in patients received each vasopressor during surgery |
| Wound exploration rate in patients received each vasopressor during surgery | Until discharge | 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 |
| Reoperation rate in patients received each vasopressor during surgery | Until discharge | 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 |
| Rate of vascular thrombosis in patients received each vasopressor during surgery | Within seven days after 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 |
| Cardiac index during surgery in patients received each vasopressor | intraoperative period | Cardiac index (in L/min/m\^2) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor |
| Total amount of remifentanil infused during surgery in patients received each vasopressor | intraoperative period | The total amount of remifentanil infused during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery |
Countries
South Korea
Outcome results
None listed