Effects of Vasopressor on the Graft Blood Flow in TRAM

Not Applicable

Completed

• Conditions: Flap Necrosis; Flap Ischemia; Blood Flow; Anastomotic Failure of Flap
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT05049278
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Study Start: 2021-09-24
• Primary Completion: 2022-02-23
• Study Completion: 2023-02-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine	Phenylephrine	Phenylephrine hydrochloride : 10 mg/1 mL
Norepinephrine	Norepinephrine	Norepinephrine Bitartrate Hydrate : 4 mg/4 mL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of