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

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 Overview

• Status: Completed
• Conditions: Blood Flow; Flap Necrosis; Flap Ischemia; Anastomotic Failure of Flap
• Intervention / Treatment: Drug: Norepinephrine; Drug: Phenylephrine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Norepinephrine; Norepinephrine Bitartrate Hydrate : 4 mg/4 mL	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)
Active Comparator: Phenylephrine; Phenylephrine hydrochloride : 10 mg/1 mL	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure rate in patients received each vasopressor during surgery	The rate of graft failure in patients received each vasopressor during surgery	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	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	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	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	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	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	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	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	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	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	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	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	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	Until discharge

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Norepinephrine; Blood flow; Vasopressor; Phenylephrine; Failure of Flap
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Necrosis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Norepinephrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: TRAM_Vasopressor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No