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The effect of thoracic epidural anaesthesia with general anaesthesia on mean systemic filling pressure, venous return and cardiac function


- candidate number19271
- NTR NumberNTR4726
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-aug-2014
- Secondary IDsP14.045 Commissie Medische Ethiek LUMC
- Public TitleThe effect of thoracic epidural anaesthesia with general anaesthesia on mean systemic filling pressure, venous return and cardiac function
- Scientific TitleThe effect of thoracic epidural anaesthesia with general anaesthesia on mean systemic filling pressure, venous return and cardiac function
- ACRONYM
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedThoracic Epidural Anesthesia (TEA), Cardiac output
- Inclusion criteriaAll 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-aug-2014
- planned closingdate15-aug-2015
- Target number of participants10
- Interventionsthoracic epidural anaesthesia with general anaesthesia
- Primary outcome- 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- 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.
- TimepointsAt baseline, systolic/ diastolic/ mean arterial pressure, central venous pressure, heart rate, temperature, pulmonary artery wedge pressure, cardiac output (Modelflow, Vigileo), stroke volume variation, pulse pressure variation, stroke volume and mean systemic filling pressure are measured. Following baseline measurements 6 ml ropivacain 0.75% is administered over the epidural catheter. 30 minutes later the measurements are repeated. Consequently, noradrenalin is infused at 0.05 ΅g•kg-1•min-2. The measurements are performed 15 minutes after noradrenalin 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. J. Wink
- CONTACT for SCIENTIFIC QUERIESDrs. J. Wink
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD10-aug-2014 - 6-sep-2014


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