Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- LIMA free flow
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All surgical procedures and measurements were carried out by a single surgeon (MBI) who was blinded to the topical agent which was applied.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing elective primary coronary artery bypass grafting
排除标准
- •patients who developed ischemic events during surgery
研究组 & 干预措施
Group 1: Normal saline
Patients in this group were randomly assigned to receive the topical application of normal saline (0.9% sodium chloride solution) on the LIMA graft as control
干预措施: The topical application of a vasodilator on the LIMA graft (Drug)
Group 2: Nitroglycerin
Patients were randomly assigned to receive the topical application of nitroglycerin (Caspian Tamin Pharmaceutical, Guilan, Iran) 10 mg in 20 ml of normal saline on the LIMA graft.
干预措施: The topical application of a vasodilator on the LIMA graft (Drug)
Group 3: milrinone
Patients were randomly assigned to receive the topical application of milrinone (Baxter Pharmaceuticals, Ahmedabad, India) on the LIMA graft
干预措施: The topical application of a vasodilator on the LIMA graft (Drug)
结局指标
主要结局
LIMA free flow
时间窗: Immediately following harvesting the LIMA and 10 mintues following the topical application of the drug
Reading the volume of blood ejected from the tip of the freely bleeding IMA through a one-minute period
次要结局
未报告次要终点
研究者
Mohammad Bashar Izzat
Professor
Damascus University
