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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Active Comparator | Patients after CABG with morphine postoperative analgesia |
|
| Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) | Experimental | Patients after CABG with tafalgin postoperative analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) | Drug | Postoperative analgesia after CABG with tafalgin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression or compare pain severity between patients | 24 hours after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Blood Gases (ABGs) pH | Arterial blood gases are a diagnostic test measuring pH levels in arterial blood to evaluate lung function and acid-base balance. | 24 hours after CABG |
| Arterial Blood Gases (ABGs) oxygen (PaO2) levels |
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Inclusion Criteria:
Exclusion Criteria (the presence of at least one is sufficient):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladislav Rublev, PhD | Contact | +79644530700 | dr.rublev.v@gmail.com | |
| Evgenii Kokarev, PhD | Contact | +79098591131 | kokareve@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Evgenii Kokarev, PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primorsky Regional General Hospital #1 | Recruiting | Vladivostok | Outside US | 690091 | Russia |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine (+) | Drug | Postoperative analgesia wtih morphine |
|
Arterial blood gases are a diagnostic test measuring oxygen (PaO2) levels in arterial blood to evaluate lung function and acid-base balance.
| 24 hours after CABG |
| Arterial Blood Gases (ABGs) carbon dioxide (PaCO2) levels | Arterial blood gases are a diagnostic test measuring carbon dioxide (PaCO2) levels in arterial blood to evaluate lung function and acid-base balance. | 24 hours after CABG |
| Haemodynamics evaluation (Intra-arterial blood pressure (IABP)) | Intra-arterial blood pressure (IABP) monitoring provides continuous, real-time arterial pressure measurement, serving as the gold standard for managing hypertension in critical care. | 24 hours after CABG |
| Haemodynamics evaluation (Heart rate (HR)) | This assessment evaluates cardiac function, identifies rhythm irregularities | 24 hours after CABG |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |