Neuroaxial Prophylaxis for CABG

Early Phase 1

• Conditions: Coronary Artery Occlusion
• Interventions: Procedure: CABG; Drug: thoracic epidural analgesia; Drug: analgesia of opioids

• Registration Number: NCT04244435
• Lead Sponsor: Volgograd State Medical University

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.

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Study Start: 2020-02-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-21
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• coronary artery bypass grafting

Exclusion Criteria

• Absolute contraindications for the use of thoracic epidural analgesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG	CABG	coronary artery bypass grafting with and without cardiopulmonary bypass
Thoracic epidural analgesia	CABG	CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period
Thoracic epidural analgesia	thoracic epidural analgesia	CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period
Opioids	analgesia of opioids	CABG and opioids will be used for perioperative analgesia
Opioids	CABG	CABG and opioids will be used for perioperative analgesia

Primary Outcome Measures

Name	Time	Method
hospital mortality	1 year
Duration of treatment in the intensive care unit	up to 1 year
Hospitalization duration	1 year

Secondary Outcome Measures

Name	Time	Method
Complications	1 year

Trial Locations

Locations (1)

Hospital №1 of Volgograd State Medical University; 🇷🇺 Volgograd, Russian Federation