NCT04244435

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

January 20, 2020

Last Update Submit

September 19, 2021

Conditions

Coronary Artery Occlusion

Keywords

coronary artery bypass graftingprevention of complicationneuroaxial prophylaxisthoracic epidural analgesia

Outcome Measures

Primary Outcomes (3)

  • hospital mortality

    1 year

  • Hospitalization duration

    1 year

  • Duration of treatment in the intensive care unit

    up to 1 year

Secondary Outcomes (1)

  • Complications

    1 year

Study Arms (3)

Thoracic epidural analgesia

EXPERIMENTAL

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

Procedure: CABGDrug: thoracic epidural analgesia

Opioids

ACTIVE COMPARATOR

CABG and opioids will be used for perioperative analgesia

Procedure: CABGDrug: analgesia of opioids

CABG

ACTIVE COMPARATOR

coronary artery bypass grafting with and without cardiopulmonary bypass

Procedure: CABG

Interventions

CABGPROCEDURE

coronary artery bypass grafting with and without cardiopulmonary bypass

CABGOpioidsThoracic epidural analgesia
thoracic epidural analgesiaDRUG

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

Thoracic epidural analgesia
analgesia of opioidsDRUG

Opioids will be used for perioperative analgesia

Opioids

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary artery bypass grafting

You may not qualify if:

  • Absolute contraindications for the use of thoracic epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital №1 of Volgograd State Medical University

Volgograd, 400079, Russia

Location

MeSH Terms

Conditions

Coronary Occlusion

Interventions

Tea

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 28, 2020

Study Start

February 1, 2020

Primary Completion

December 31, 2020

Study Completion

January 31, 2022

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

RU(1)