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Clinical Trials/NCT04244435
NCT04244435
Unknown
Early Phase 1

Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting

Volgograd State Medical University1 site in 1 country300 target enrollmentFebruary 1, 2020

Overview

Phase
Early Phase 1
Intervention
CABG
Conditions
Coronary Artery Occlusion
Sponsor
Volgograd State Medical University
Enrollment
300
Locations
1
Primary Endpoint
hospital mortality
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Volgograd State Medical University
Responsible Party
Principal Investigator
Principal Investigator

Mikhail I Turovets, MD

professor

Volgograd State Medical University

Eligibility Criteria

Inclusion Criteria

  • coronary artery bypass grafting

Exclusion Criteria

  • Absolute contraindications for the use of thoracic epidural analgesia

Arms & Interventions

Thoracic epidural analgesia

CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period

Intervention: CABG

Thoracic epidural analgesia

CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period

Intervention: thoracic epidural analgesia

Opioids

CABG and opioids will be used for perioperative analgesia

Intervention: CABG

Opioids

CABG and opioids will be used for perioperative analgesia

Intervention: analgesia of opioids

CABG

coronary artery bypass grafting with and without cardiopulmonary bypass

Intervention: CABG

Outcomes

Primary Outcomes

hospital mortality

Time Frame: 1 year

Duration of treatment in the intensive care unit

Time Frame: up to 1 year

Hospitalization duration

Time Frame: 1 year

Secondary Outcomes

  • Complications(1 year)

Study Sites (1)

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