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Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow

Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06301880
Enrollment
46
Registered
2024-03-08
Start date
2022-01-01
Completion date
2023-01-31
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internal Mammary Artery Syndrome, Vasodilation

Keywords

milrinone, graft, coronary artery bypass grafting, spasm

Brief summary

Forty-six consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled. After the left IMA was harvested, free flow was measured under controlled hemodynamic conditions before any intervention (flow 1) and at a mean of 12.5 minutes after the topical application of one of three agents (milrinone, nitroglycerin or normal saline) on the IMA (flow 2).

Detailed description

Fifty consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study. Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control. All surgical procedures and measurements were carried out by a single surgeon who was blinded to the topical agent which was applied. Each patient enrolled in the study gave a written informed consent, and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the local human research committee. Operative Technique After sternal incision, the skeletonized left IMA was harvested from the subclavian artery to its bifurcation with low-powered electrocautery, and major collaterals were ligated with hemoclips. Following systemic heparinization (300 units/kg to achieve an activated clotting time target of 480 seconds), the IMA was divided proximal to its bifurcation. The first IMA flow (flow 1) was measured by reading the volume of blood ejected from the tip of the freely bleeding IMA through a one-minute period. Heart rate, mean arterial pressure and central venous pressure were documented at the same time. The tip of the artery was occluded with a bulldog clamp, and a swab which was soaked with the selected vasodilator at room temperature (18.0 to 20.0 degrees C) was wrapped around the IMA, and was left undisturbed until the second set of measurements. Cannulation for cardiopulmonary bypass was carried out, and the pump was used to transfuse or drain blood from the patient in order to restore the mean arterial and central venous pressures as nearly as possible to the previous values. Systemic vasopressors or vasodilators were not used. The IMA was then unwrapped and the second IMA flow (flow 2) was measured in the same way. Time, heart rate, and mean arterial and central venous pressures were also recorded.

Interventions

DRUGThe topical application of a vasodilator on the LIMA graft

Patients were randomly assigned to receive the topical application of one of three agents: milrinone (Baxter Pharmaceuticals, Ahmedabad, India) 10 mg in 20 ml of dextrose 5%, nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline, or normal saline (0.9% sodium chloride solution) as control.

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

All surgical procedures and measurements were carried out by a single surgeon (MBI) who was blinded to the topical agent which was applied.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* patients undergoing elective primary coronary artery bypass grafting

Exclusion criteria

* patients who developed ischemic events during surgery

Design outcomes

Primary

MeasureTime frameDescription
LIMA free flowImmediately following harvesting the LIMA and 10 mintues following the topical application of the drugReading the volume of blood ejected from the tip of the freely bleeding IMA through a one-minute period

Countries

Syria

Contacts

PRINCIPAL_INVESTIGATORMohammad Bashar Izzat, FRCS(CTh)

Damascus University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026