Clinical trial NCT05049278: Effects of Vasopressor on the Graft Blood Flow in TRAM
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Flow
Anastomotic Failure of Flap
Flap Necrosis
Flap Ischemia
Keywords: Blood flow
Failure of Flap
Vasopressor
Phenylephrine
Norepinephrine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Graft mean blood flow measured using transit time flowmetry
timeFrame: Intraoperative period
measure: Pulsatility of graft vessel measured using transit time flowmetry
timeFrame: Intraoperative period
measure: Diastolic filling of the graft vessel measured using transit time flowmetry
timeFrame: Intraoperative period
Secondary outcomes:
measure: Graft failure rate in patients received each vasopressor during surgery
timeFrame: Within seven days after surgery
measure: Capillary filling time in patients received each vasopressor during surgery
timeFrame: Within seven days after surgery
measure: Skin necrosis rate in patients received each vasopressor during surgery
timeFrame: Within seven days after surgery
measure: Rate of vascular thrombosis in patients received each vasopressor during surgery
timeFrame: Within seven days after surgery
measure: Rate of wound infection or any wound problem in patients received each vasopressor during surgery
timeFrame: Within seven days after surgery
measure: Amount of transfusion in patients received each vasopressor during surgery
timeFrame: Within seven days after surgery
measure: Total amount of remifentanil infused during surgery in patients received each vasopressor
timeFrame: intraoperative period
measure: Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor
timeFrame: intraoperative period
measure: Stroke volume during surgery in patients received each vasopressor
timeFrame: intraoperative period
measure: Cardiac index during surgery in patients received each vasopressor
timeFrame: intraoperative period
measure: Stroke volume variation during surgery in patients received each vasopressor
timeFrame: intraoperative period
measure: Serum lactate levels in patients received each vasopressor
timeFrame: Within seven days after surgery
measure: Wound exploration rate in patients received each vasopressor during surgery
timeFrame: Until discharge
measure: Reoperation rate in patients received each vasopressor during surgery
timeFrame: Until discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: