In the present study we will determine the effect of sympathetic blockade by TEA on major outcome parameters after off-pump CABG.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the composite outcome of 30 days all
cause mortality, myocardial infarction, stroke or renal failure requiring
dialysis.
Secondary outcome
The secondary endpoints are the separate components of the composite outcome.
Background summary
Thoracic epidural anesthesia (TEA) with local anesthetics is potentially the
preferable anesthetic technique to protect the heart during off pump beating
heart surgery against myocardial ischemia. However, the largest trial until now
(Anesthesiology 2011; 114:262*70), comparing general anesthesia alone with
anesthesia supplemented by TEA did not demonstrate beneficial effects on
mortality, myocardial infarction, renal failure or stroke. However, the
majority of these patients were operated with the use of heart-lung machine
(and aortic cross clamping) and for valve surgery.
Study objective
In the present study we will determine the effect of sympathetic blockade by
TEA on major outcome parameters after off-pump CABG.
Study design
This is a randomized, single center , unblinded study, comparing the effect of
general anesthesia with TEA versus general anesthesia alone (TEA versus GA) on
the composite outcome of 30 days all cause mortality, myocardial infarction,
stroke or renal failure requiring dialysis in patients scheduled for off pump
CABG.
Intervention
General anesthesia alone or general anesthesia supplemented by TEA.
Study burden and risks
This is an observational study, comparing two established anesthesia
techniques. Obviously, the study itself is without any risk
Haaksbergerstraat 55
Enschede 7531 ER
NL
Haaksbergerstraat 55
Enschede 7531 ER
NL
Listed location countries
Age
Inclusion criteria
-Men + Women 18 years or more
-Planned off pump CABG
-life expectancy at least 2 years
-fulfilled the criteria for the anticoagulation status to perform an epidural puncture
Exclusion criteria
-no other off pump procedures planned (such as mini Maze)
-ongoing myocardial infarction or recent myocardial infarction in whom the cardiac enzymes have not returned to normal values
-necessitating intra aortic counter pulsation (left main stenosis)
-chronic renal failure, necessitating dialysis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47387.044.14 |