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Completed

NCT Number: NCT05049278

Effects of Vasopressor on the Graft Blood Flow in TRAM

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.

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Key information

Conditions

Blood Flow Anastomotic Failure of Flap Flap Ischemia Flap Necrosis

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug
  • 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)

Phenylephrine

Drug
  • 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)

Primary outcomes

  1. Graft mean blood flow measured using transit time flowmetry

    Time frame: Intraoperative period

    Mean blood flow (in mL/min) of the graft vessel that was measured using transit time flowmetry

  2. Pulsatility of graft vessel measured using transit time flowmetry

    Time frame: Intraoperative period

    Pulsatility of graft vessel, which is presented as pulsatility index in unitless, that was measured using transit time flowmetry

  3. Diastolic filling of the graft vessel measured using transit time flowmetry

    Time frame: Intraoperative period

    Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry

Secondary outcomes

  1. Graft failure rate in patients received each vasopressor during surgery

    Time frame: Within seven days after surgery

    The rate of graft failure in patients received each vasopressor during surgery

  2. Capillary filling time in patients received each vasopressor during surgery

    Time frame: 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

  3. Skin necrosis rate in patients received each vasopressor during surgery

    Time frame: 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

  4. Rate of vascular thrombosis in patients received each vasopressor during surgery

    Time frame: 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

  5. Rate of wound infection or any wound problem in patients received each vasopressor during surgery

    Time frame: 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

  6. Amount of transfusion in patients received each vasopressor during surgery

    Time frame: Within seven days after surgery

    Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery

  7. Total amount of remifentanil infused during surgery in patients received each vasopressor

    Time frame: intraoperative period

    The total amount of remifentanil infused during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery

  8. Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor

    Time frame: 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

  9. Stroke volume during surgery in patients received each vasopressor

    Time frame: intraoperative period

    Stroke volume (in mL) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor

  10. Cardiac index during surgery in patients received each vasopressor

    Time frame: intraoperative period

    Cardiac index (in L/min/m^2) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor

  11. Stroke volume variation during surgery in patients received each vasopressor

    Time frame: intraoperative period

    Stroke volume variation (in percentage) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor

  12. Serum lactate levels in patients received each vasopressor

    Time frame: 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

  13. Wound exploration rate in patients received each vasopressor during surgery

    Time frame: 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

  14. Reoperation rate in patients received each vasopressor during surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 20, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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