Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- visual-analog scale
研究概览
简要总结
The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.
详细描述
The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the envelope method). The drug Neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. The second injection will be prescribed at VAS > 40 mm no earlier than 12 hours after the first. The first injection will begin immediately after tracheal extubation. Morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age from 18 years to 80 years inclusive
- •surgical access - median sternotomy
- •the first 2 hours after tracheal extubation
- •clear consciousness and productive contact with the patient
- •absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding
- •no signs of renal dysfunction (KDIGO 0)
- •stable state of hemodynamics
排除标准
- •a history of mental illness
- •the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups
- •renal and hepatic insufficiency
- •perioperative brain lesions
- •postoperative bleeding>1.4 ml/kg/hour
- •severe cardiovascular (inotropic index>10) and/or respiratory (RaO2 /FiO2<200 mmHg) insufficiency
研究组 & 干预措施
the first group: a fixed combination of Orphenadrine and Diclofenac
dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume
干预措施: Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi) (Drug)
the second group: patient-controlled analgesia (РСА) with Morphine
dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume
干预措施: Analgesics (Drug)
结局指标
主要结局
visual-analog scale
时间窗: hospitalisation period, an average of 24 hours
dynamics of points 100 mm visual-analog scale
次要结局
- the minute inspiratory lung volume using a spirometer(hospitalisation period, an average of 24 hours)
- opioid-sparing effect(hospitalisation period, an average of 24 hours)
- adverse events(hospitalisation period, an average of 1 week)
研究者
Aleksandr Eremenko
Clinical Professor
Petrovsky National Research Centre of Surgery