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临床试验/NCT06301880
NCT06301880已完成3 期

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

Damascus University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Bashar Izzat

Professor

Damascus University

研究点 (1)

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