Neuroaxial Prophylaxis for CABG

NCT ID: NCT04244435

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thoracic epidural analgesia

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

Group Type EXPERIMENTAL

CABG

Intervention Type PROCEDURE

coronary artery bypass grafting with and without cardiopulmonary bypass

thoracic epidural analgesia

Intervention Type DRUG

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

Opioids

CABG and opioids will be used for perioperative analgesia

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type PROCEDURE

coronary artery bypass grafting with and without cardiopulmonary bypass

analgesia of opioids

Intervention Type DRUG

Opioids will be used for perioperative analgesia

CABG

coronary artery bypass grafting with and without cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type PROCEDURE

coronary artery bypass grafting with and without cardiopulmonary bypass

Interventions

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CABG

coronary artery bypass grafting with and without cardiopulmonary bypass

Intervention Type PROCEDURE

thoracic epidural analgesia

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

Intervention Type DRUG

analgesia of opioids

Opioids will be used for perioperative analgesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* coronary artery bypass grafting

Exclusion Criteria

* Absolute contraindications for the use of thoracic epidural analgesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Volgograd State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mikhail I Turovets, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital №1 of Volgograd State Medical University

Volgograd, , Russia

Site Status

Countries

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Russia

Other Identifiers

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TEA-CABG

Identifier Type: -

Identifier Source: org_study_id

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