To evaluate the effects of thoracic epidural anaesthesia (TEA) with general anaesthesia on mean systemic filling pressures, arterial- and venous resistance and cardiac output.To assess the hemodynamic effects of vasopressors and fluid loading under…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
effecten van sympathicusblokkade door epidurale anesthesie met algehele anesthesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectives of this study consist of:
- To evaluate the effects of thoracic epidural anaesthesia (TEA) under general
anaesthesia on mean systemic filling pressures, arterial- and venous resistance
and cardiac output.
Secondary outcome
Secondary objectives consist of:
- To assess the hemodynamic effects of vasopressors and fluid loading under TEA
with general anaesthesia conditions
- To assess the value of stroke volume variation and pulse pressure
variation,to predict fluid loading responsiveness with TEA.
Background summary
The analgesic effects of thoracic epidural anaesthesia (TEA) have been studied
extensively including by our own group. Less is known, however, about the
hemodynamic effects of TEA. Consequently, the hemodynamic management after TEA
induction varies wildly. Some anaesthetists will start with fluid loading to
address hypotension and others will start using vasopressor medication first.
In this study, we evaluate the hemodynamic effect of TEA on heart function with
a Swan-Ganz catheter, venous and arterial pressure, and venous and arterial
resistance. Consequently we try to assess the best haemodynamic strategy to
offset these hemodynamic effects either by fluid loading or vasopressor
medication.
Study objective
To evaluate the effects of thoracic epidural anaesthesia (TEA) with general
anaesthesia on mean systemic filling pressures, arterial- and venous resistance
and cardiac output.
To assess the hemodynamic effects of vasopressors and fluid loading under TEA
with general anaesthesia conditions.
To assess the value of stroke volume variation and pulse pressure variation to
predict fluid loading responsiveness with TEA.
Study design
Explorative prospective intervention and measurement study
Intervention
Noradrenalin infusion is started 30 minutes after induction of TEA. The
measurements are performed 15 minutes after noradrenalin infusion is started.
Noradrenalin infusion is stopped and baseline measurements are repeated after
15 minutes. 4 ml*kg-1 crystalloids are administered in 10 minutes. Study
participation is terminated after the final measurements are taken 10 minutes
after fluid administration.
Study burden and risks
Anaesthesia will be according to normal routine with the exception that a
longer central line (Swan Ganz catheter) will be placed. This procedure
involves no extra risks when performed by anesthesiologists with SG catheters,
which is the case in this study.
There will be no extra risks for the patients, but benefits either. Patients
will not be paid for inclusion.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
All adult patients scheduled for lung surgery under thoracic epidural and general anaesthesia
Exclusion criteria
* Participation in a trial on investigational drugs within 3 months prior to the study
* Hemodynamic instability prior to start of measurements with the systolic blood pressure decreasing more than 30% below the pre-anaesthetic value or a mean arterial pressure (MAP) < 60 mm Hg, central venous pressure (CVP) >18 mm Hg and/ or a cardiac index < 2.0 L*min-1 or dependence on high dosages of inotropic drugs after induction of general anaesthesia and before TEA.
* Severe arrhythmias
* Intra-cardiac shunts
* Prior diagnosis of aberrant cardiovascular anatomy
* Symptomatic peripheral vascular disease
* Severe chronic obstructive pulmonary disease (GOLD III or IV, or proven existence of lung bullae)
* Clinically significant aortic aneurysm
* Significant valvular regurgitation
* Use of lithium medication
* Diabetes requiring insulin therapy
* On beta blocker or calcium antagonist medication
* Contra-indications to epidural anaesthesia: - Increased risk of bleeding induced by medication or bleeding disorders
- Local infection at the insertion site
- Anatomic abnormalities of the spine
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 | NL48092.058.14 |