Back to resultsNeuroaxial Prophylaxis for CABG
Primary Purpose
Coronary Artery Occlusion
Status
Unknown status
Phase
Early Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
CABG
thoracic epidural analgesia
analgesia of opioids
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Occlusion focused on measuring coronary artery bypass grafting, prevention of complication, neuroaxial prophylaxis, thoracic epidural analgesia
Eligibility Criteria
Inclusion Criteria:
- coronary artery bypass grafting
Exclusion Criteria:
- Absolute contraindications for the use of thoracic epidural analgesia
Sites / Locations
- Hospital №1 of Volgograd State Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Thoracic epidural analgesia
Opioids
CABG
Arm Description
CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period
CABG and opioids will be used for perioperative analgesia
coronary artery bypass grafting with and without cardiopulmonary bypass
Outcomes
Primary Outcome Measures
hospital mortality
Hospitalization duration
Duration of treatment in the intensive care unit
Secondary Outcome Measures
Complications
Full Information
NCT ID
NCT04244435
First Posted
January 20, 2020
Last Updated
September 19, 2021
Sponsor
Volgograd State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04244435
Brief Title
Neuroaxial Prophylaxis for CABG
Official Title
Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Volgograd State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Occlusion
Keywords
coronary artery bypass grafting, prevention of complication, neuroaxial prophylaxis, thoracic epidural analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thoracic epidural analgesia
Arm Type
Experimental
Arm Description
CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period
Arm Title
Opioids
Arm Type
Active Comparator
Arm Description
CABG and opioids will be used for perioperative analgesia
Arm Title
CABG
Arm Type
Active Comparator
Arm Description
coronary artery bypass grafting with and without cardiopulmonary bypass
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Description
coronary artery bypass grafting with and without cardiopulmonary bypass
Intervention Type
Drug
Intervention Name(s)
thoracic epidural analgesia
Intervention Description
thoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h)
Intervention Type
Drug
Intervention Name(s)
analgesia of opioids
Intervention Description
Opioids will be used for perioperative analgesia
Primary Outcome Measure Information:
Title
hospital mortality
Time Frame
1 year
Title
Hospitalization duration
Time Frame
1 year
Title
Duration of treatment in the intensive care unit
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Complications
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary artery bypass grafting
Exclusion Criteria:
Absolute contraindications for the use of thoracic epidural analgesia
Facility Information:
Facility Name
Hospital №1 of Volgograd State Medical University
City
Volgograd
ZIP/Postal Code
400079
Country
Russian Federation
12. IPD Sharing Statement
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Neuroaxial Prophylaxis for CABG
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