CAD - Coronary Artery Disease, CABG, Analgesia Assessment
Conditions
Keywords
CABG, CAD, Morphine, Tafalgin, VAS
Brief summary
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.
Interventions
DRUGTafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)
Postoperative analgesia after CABG with tafalgin
DRUGMorphine (+)
Postoperative analgesia wtih morphine
Sponsors
Primorsky Regional General Hospital #1
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Blood Gases (ABGs) pH | 24 hours after CABG | Arterial blood gases are a diagnostic test measuring pH levels in arterial blood to evaluate lung function and acid-base balance. |
| Arterial Blood Gases (ABGs) oxygen (PaO2) levels | 24 hours after CABG | Arterial blood gases are a diagnostic test measuring oxygen (PaO2) levels in arterial blood to evaluate lung function and acid-base balance. |
| Arterial Blood Gases (ABGs) carbon dioxide (PaCO2) levels | 24 hours after CABG | Arterial blood gases are a diagnostic test measuring carbon dioxide (PaCO2) levels in arterial blood to evaluate lung function and acid-base balance. |
| Haemodynamics evaluation (Intra-arterial blood pressure (IABP)) | 24 hours after CABG | Intra-arterial blood pressure (IABP) monitoring provides continuous, real-time arterial pressure measurement, serving as the gold standard for managing hypertension in critical care. |
| Haemodynamics evaluation (Heart rate (HR)) | 24 hours after CABG | This assessment evaluates cardiac function, identifies rhythm irregularities |
Countries
Russia
Contacts
CONTACTVladislav Rublev, PhD
CONTACTEvgenii Kokarev, PhD
PRINCIPAL_INVESTIGATOREvgenii Kokarev, PhD
Outcome results
None listed