Comparative Characteristics of Analgesia Methods in the Early Postoperative Period After Coronary Artery Bypass Grafting (CABG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to study postoperative analgesia in patients undergoing CABG. And learn if tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) treats pain not inferiory then morphine. The main questions it aims to answer are:
Does tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) lower the VAS score same way as a morphine? What medical problems do participants have when taking tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid)?
Participants will:
Group (1)- subcutaneous single dose of morphine 10 mg would be administred based on VAS score > 3 during 24 hours after CABG.
Exprimental group (2)- subcutaneous single dose of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) - 0.4 mg would be administred based on VAS score > 3 during 24 hours after CABG.
Efficacy was assessed using the VAS scale decreassion. Hemodynamic parameters and arterial blood gases were also assessed.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA score less then 3, Signed inform consent, Absence of preoperative drugs administration that affects patient's perception of pain, No active infection process, BMI index >18,5 kg\m2 and < 35 kg/m2, CABG, Age 18-75 years
排除标准
- •(the presence of at least one is sufficient):
- •Failure to meet the inclusion criteria.
- •High severity according to ASA (class IV or higher), which is associated with a high probability of prolonged mechanical ventilation, hemodynamic instability, and inability to use drugs affecting cardiac output and/or total peripheral vascular resistance.
- •Contraindications to the use of tafalgin and/or morphine in accordance with the approved Summary of Product Characteristics (hypersensitivity to tafalgin, morphine, other opioids, or any excipients).
- •Pregnancy or lactation.
- •Acute or prolonged chronic intoxication with drugs or substances depressing the central nervous system (alcohol, barbiturates, opioid drugs, benzodiazepines).
- •Use of monoamine oxidase inhibitors (MAOIs) or less than 14 days since their discontinuation.
- •Liver cirrhosis, Child-Pugh class C.
- •Acute renal failure requiring renal replacement therapy.
- •Unresected malignant neoplasm.
- •Mesenteric thrombosis or another severe abdominal pain syndrome of unclear etiology at the time of inclusion.
- •Simultaneous participation in another clinical study.
- •Marked CNS depression due to any cause, except for acute poisoning.
- •COPD stage III and/or bronchial asthma in the exacerbation phase.
- •Any clinically significant condition, disease, or circumstance in the medical history that, in the opinion of the investigator, precludes participation in the study.
- •Psychiatric, physical, or other conditions preventing adequate assessment of the patient's behavior or proper compliance with the study protocol.
- •Postoperative hemodynamic instability requiring high-dose inotropic and/or vasopressor support (epinephrine > 0.1 μg/kg/min, dopamine > 10 μg/kg/min, norepinephrine > 0.2 μg/kg/min) and/or mechanical circulatory support.
- •Refusal to participate in the study.
研究组 & 干预措施
Morphine
Patients after CABG with morphine postoperative analgesia
干预措施: Morphine (+) (Drug)
Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)
Patients after CABG with tafalgin postoperative analgesia
干预措施: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 24 hours after CABG
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients
次要结局
- Arterial Blood Gases (ABGs) pH(24 hours after CABG)
- Arterial Blood Gases (ABGs) oxygen (PaO2) levels(24 hours after CABG)
- Arterial Blood Gases (ABGs) carbon dioxide (PaCO2) levels(24 hours after CABG)
- Haemodynamics evaluation (Intra-arterial blood pressure (IABP))(24 hours after CABG)
- Haemodynamics evaluation (Heart rate (HR))(24 hours after CABG)
研究者
Vladislav Rublev
Head of EP, Principal Investigator, MD, PhD
Primorsky Regional General Hospital #1