Comparative Analysis of Analgesic Approaches in the Early Period After CABG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPrimorsky Regional General Hospital #1
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)
DrugPostoperative analgesia after CABG with tafalgin
Morphine (+)
DrugPostoperative analgesia wtih morphine
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: MorphineActive comparator 1 intervention
Group B: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 hours after CABGSecondary outcomes
1
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.
Time frame
24 hours after CABG2
Arterial Blood Gases (ABGs) oxygen (PaO2) levels
Arterial blood gases are a diagnostic test measuring oxygen (PaO2) levels in arterial blood to evaluate lung function and acid-base balance.
Time frame
24 hours after CABG3
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.
Time frame
24 hours after CABG4
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.
Time frame
24 hours after CABGSponsors and contacts
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Source ClinicalTrials.gov