Aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.
ID
Source
Brief title
Condition
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the total amount of the vasopressor phenylephrine
that is needed to maintain blood pressure above 60 mmHg during 10 minutes of
CPB.
Secondary outcome
Secondary outcome measures are mean blood pressure throughout the 10 minute
periods, the need for a stronger vasopressor (norepinephrine) and the inability
to keep mean blood pressure below 75 mmHg at MAC 0.6.
Background summary
In modern anesthesia a variety of volatile anesthetics is available. To decide
which anesthetic should be used in different settings, it is relevant to know
the beneficial and side effects of these anesthetics.
An ideal volatile anesthetic agent should have a number of qualities, which all
contribute to the ease of use and the safety of the patient.
Like virtually all anesthetics, volatile anesthetics are known to decrease
blood pressure. During cardiac surgery, and especially during open-heart
surgery with the use of the cardiopulmonary bypass, maintenance of adequate
blood pressure is important, because severe hypotension is associated with poor
clinical outcomes.
At present both isoflurane and sevoflurane are frequently used in cardiac
anesthesiology.
It is unclear, however, to which degree isoflurane and sevoflurane decrease
blood pressure and whether this effect is predominantly caused by depression of
myocardial contractility or a decrease in systemic vascular resistance (SVR).
The decision as to which of both volatiles should be used during cardiac
surgery is therefore not evidence-based, but is based on personal preference of
the anesthesist.
At present the number of studies comparing the influence of isoflurane and
sevoflurane on blood pressure and systemic vascular resistance is limited.
Moreover, the results presented in the available literature are inconsistent.
Although most publications did not report any significant difference between
isoflurane and sevoflurane, a small number of publications did find a possible
beneficial effect on blood pressure of sevoflurane, compared to isoflurane.
Cardiopulmonary bypass (CPB) offers an unique opportunity to study the effect
of anesthetics on SVR, without concurrent effect of changes in cardiac output.
This is because there is no contraction of the heart during CPB and other
variables that might affect blood pressure, like cardiac index, body
temperature, hematocrite and expired CO2, can be kept stable.
Study objective
Aim of this study is to determine the effect of isoflurane versus sevoflurane
on blood pressure and systemic vascular resistance.
Study design
The study is designed as a crossover randomized double-blinded controlled
single center trial.
Intervention
patients will be randomized to a 10 minute treatment with isoflurane, followed
by a wash-out period, followed by a 10 minute treatment with sevoflurane, or
the otherway round.
Study burden and risks
There is no substantial risk, nor are there any benefits for the participants.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Minimal of 18 years of age.
Patients undergoing coronary artery bypass grafting with the use of the cardiopulmonary bypass.
Exclusion criteria
Valve surgery. Combined surgical procedures. Uncontrolled hypertension. Poor left ventricular function (left ventricular ejection fraction < 30%). Renal failure. BMI > 25. History of cerebrovascular accident, transient ischemic attack or carotid artery stenosis. Participation in an other study.
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2008-005426-37-NL |
CCMO | NL24375.041.08 |