Effects of Vasopressor on the Graft Blood Flow in TRAM

NCT ID: NCT05049278

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-24
• Study Completion Date: 2023-02-23

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.

Conditions

Blood Flow; Anastomotic Failure of Flap; Flap Necrosis; Flap Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Norepinephrine

Norepinephrine Bitartrate Hydrate : 4 mg/4 mL

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: 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

Phenylephrine hydrochloride : 10 mg/1 mL

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Youn Joung Cho, MD, PhD

Seoul National University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

TRAM_Vasopressor

Identifier Type: -

Identifier Source: org_study_id