Neuroaxial Prophylaxis for CABG

Coronary Artery Occlusion Clinical Trial

Official title:

Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04244435
• Other study ID #: TEA-CABG
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: February 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: September 2021
• Source: Volgograd State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• coronary artery bypass grafting

Exclusion Criteria:

• Absolute contraindications for the use of thoracic epidural analgesia

Related Conditions & MeSH terms

• Coronary Artery Occlusion
• Coronary Occlusion

Intervention

Procedure:
• CABG
coronary artery bypass grafting with and without cardiopulmonary bypass

Drug:
• thoracic epidural analgesia
thoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h)
• analgesia of opioids
Opioids will be used for perioperative analgesia

Locations

Country	Name	City	State
Russian Federation	Hospital ?1 of Volgograd State Medical University	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
Volgograd State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital mortality		1 year
Primary	Hospitalization duration		1 year
Primary	Duration of treatment in the intensive care unit		up to 1 year
Secondary	Complications		1 year