Neuroaxial Prophylaxis for CABG

September 19, 2021 updated by: Mikhail I Turovets, MD, Volgograd State Medical University

Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Volgograd, Russian Federation, 400079
        • Hospital №1 of Volgograd State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • coronary artery bypass grafting

Exclusion Criteria:

  • Absolute contraindications for the use of thoracic epidural analgesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thoracic epidural analgesia
CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period
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)
Active Comparator: Opioids
CABG and opioids will be used for perioperative analgesia
Procedure: CABG
coronary artery bypass grafting with and without cardiopulmonary bypass
Drug: analgesia of opioids
Opioids will be used for perioperative analgesia
Active Comparator: CABG
coronary artery bypass grafting with and without cardiopulmonary bypass
Procedure: CABG
coronary artery bypass grafting with and without cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hospital mortality
Time Frame: 1 year
1 year
Hospitalization duration
Time Frame: 1 year
1 year
Duration of treatment in the intensive care unit
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volgograd State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 19, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEA-CABG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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