To investigate if there is a clinically important different effect of atropine on haemodynamic variables, tissue oxygenation or microcirculation during anaesthesia with either sufentanil and propofol or with remifentanil and propofol.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in CO (continuous measurement of the Nexfin monitor) around the
moment of atropine administration.
Secondary outcome
The evolution of MAP, SctO2 and SptO2 around the moment of atropine
administration.
Background summary
Induction of general anaesthesia with a combination of opiates and hypnotics
often induces vasodilation resulting in several haemodynamic effects such as a
decrease in blood pressure, heart rate and cardiac output. This haemodynamic
suppression may jeopardize tissue oxygenation, particularly cerebral
oxygenation. Previous research of our group (see attachments) has revealed that
atropine has an exceptionally beneficial effect on the determinants of tissue
oxygen delivery as well as on tissue oxygenation. We have demonstrated a
significant and clinically relevant increase in cardiac output (CO) and
cerebral tissue oxygenation (SctO2) for a desired increase in arterial blood
pressure. This is in steep contrast with the more usual clinical practice of
administrating classical vasoactive medication such as phenylephrine or
norepinephrine, since the two latter have an even negative effect on CO and
SctO2. In our previous research we used standardized target controlled
propofol/remifentanil infusions for induction and maintenance of anaesthesia.
It is known that remifentanil has more intense haemodynamic side-effects
compared to other opiates such as fentanyl, sufentanil or alfentanil. This
raises the question whether the beneficial effect of atropine is restricted to
propofol/remifentanil anaesthesia, or if this is equally valid during
anaesthesia of propofol combined with other opiates such as sufentanil.
Patients undergoing off-pump coronary artery bypass grafting (CABG) require a
long and deep general anaesthesia, which is usually performed with the
combination of drugs as mentioned above. Because these patients often
experience severe haemodynamic fluctuations they need to be closely monitored.
Study objective
To investigate if there is a clinically important different effect of atropine
on haemodynamic variables, tissue oxygenation or microcirculation during
anaesthesia with either sufentanil and propofol or with remifentanil and
propofol.
Study design
Prospective, double-blind, randomized, interventional trial.
Intervention
Patients will be randomised to receive anaesthesia with propofol and an
equipotent effect site concentration of either sufentanil or remifentanil
administered with target controlled infusion pumps.
Study burden and risks
In this study, we will provide standardized anaesthesia during routine
clinical practice. Both sufentanil are remifentanil are routinely used as
analgesic, with no definite advantage of either. Whether the patient will be
treated with sufentanil or remifentanil will be randomly determined. In these
patients an arterial catheter is routinely placed for continuous blood pressure
monitoring and blood sampling, consequently no additional punctures are
required for the use of the additional monitoring devices. This study will not
extent the burden for patients. As both agents are routinely used, patients
will have no additional risk or advantage compared to clinical practice.
hanzeplein 1
groningen 9713 EZ
NL
hanzeplein 1
groningen 9713 EZ
NL
Listed location countries
Age
Inclusion criteria
- Age: 18 years and older
-- Written informed consent to participate in this study.
- Elective CABG surgery performed off-pump.
- Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.
Exclusion criteria
- Refusal to participate in this study.
- Age: younger than 18 years.
- Pregnant.
- BMI > 35 kg/m2.
- Patients in which atropine is contra-indicated.
- Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
- Urgent or emergency surgery.
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 | EUCTRnl 20130219 -NL |
CCMO | NL43791.042.13 |