๐ฌIn plain words
What the trial is, and whether it could suit you
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 g
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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
Exclusion Criteria (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 ฮผg/kg/min, dopamine \> 10 ฮผg/kg/min, norepinephrine \> 0.2 ฮผg/kg/min) and/or mechanical circulatory support.
* Refusal to participate in the study.
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