Comparative Analysis of Analgesic Approaches in the Early Period After CABG

NCT07451522 | Recruiting

• 1 other identifier: LEC028
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

CAD - Coronary Artery Disease; CABG; Analgesia Assessment

Keywords

CABG; CAD; Morphine; Tafalgin; VAS

Outcome Measures

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

  24 hours after CABG

Secondary Outcomes (5)

• 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

Study Arms (2)

Morphine

ACTIVE COMPARATOR

Patients after CABG with morphine postoperative analgesia

Drug: Morphine (+)

Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)

EXPERIMENTAL

Patients after CABG with tafalgin postoperative analgesia

Drug: Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)

Interventions

Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) DRUG

Postoperative analgesia after CABG with tafalgin

Tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide)

Morphine (+) DRUG

Postoperative analgesia wtih morphine

Morphine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Primorsky Regional General Hospital #1: lead

Study Sites (1)

Primorsky Regional General Hospital #1

Vladivostok, Outside US, 690091, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Morphine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Evgenii Kokarev, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladislav Rublev, PhD

CONTACT

+79644530700; dr.rublev.v@gmail.com

Evgenii Kokarev, PhD

CONTACT

+79098591131; kokareve@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of EP, Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 5, 2026
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

RU (1)