Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301880
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Brief Title:
Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 125 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 09 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 unitskg 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 180 to 200 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
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 unitskg 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 180 to 200 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None