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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05049278
Other study ID # TRAM_Vasopressor
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2021
Est. completion date February 23, 2023

Study information

Verified date April 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 23, 2023
Est. primary completion date February 23, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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