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Neuroaxial Prophylaxis for CABG

Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04244435
Enrollment
300
Registered
2020-01-28
Start date
2020-02-01
Completion date
2022-01-31
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Occlusion

Keywords

coronary artery bypass grafting, prevention of complication, neuroaxial prophylaxis, thoracic epidural analgesia

Brief summary

Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.

Detailed description

Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.

Interventions

PROCEDURECABG

coronary artery bypass grafting with and without cardiopulmonary bypass

DRUGthoracic epidural analgesia

thoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h)

DRUGanalgesia of opioids

Opioids will be used for perioperative analgesia

Sponsors

Volgograd State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* coronary artery bypass grafting

Exclusion criteria

* Absolute contraindications for the use of thoracic epidural analgesia

Design outcomes

Primary

MeasureTime frame
hospital mortality1 year
Hospitalization duration1 year
Duration of treatment in the intensive care unitup to 1 year

Secondary

MeasureTime frame
Complications1 year

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026