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Cardiac effects of high thoracic epidural anaesthesia during bicycle exercise: an echocardiographic study


- candidate number20885
- NTR NumberNTR4880
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2014
- Secondary IDsP14.044 Medical Ethics Committee LUMC
- Public TitleCardiac effects of high thoracic epidural anaesthesia during bicycle exercise: an echocardiographic study
- Scientific TitleCardiac effects of high thoracic epidural anaesthesia during bicycle exercise: an echocardiographic study
- ACRONYM
- hypothesisWe hypothesize that the circulatory and cardiac effects of TEA will be most pronounced during circumstances of increased sympathicotonus, which will be induced by an exercise test on a bicycle.
- Healt Condition(s) or Problem(s) studiedEpidural analgesia, Ventricular function, Bicycle ergometry
- Inclusion criteria- Younger than 65 years
- ASA 1 or 2 patients undergoing thoracic surgery under thoracic epidural anaesthesia
- Exclusion criteriaContra-indications for thoracic epidural:
• Infection of the skin in the area of the epidural site
• A history of neurological diseases
• A history of bleeding diathesis
• Muscle diseases
• Hypersensitive to local anesthetics
History of Coronary Artery disease (CAD)
Known decreased ejection < 40 %
Known severe regurgitation or stenosis of a heart valve (grade 3 or 4)
Heart rhythm other than sinus rhythm
Existence of diabetes mellitus
Use of B-blockers or Calcium-antagonists
Pregnancy or lactation
Participation in a trial on investigational drugs within 3 months prior to the study
Participation in trial P14.045: “The effect of thoracic epidural anaesthesia with general anaesthesia on mean systemic filling pressure, venous return and cardiac function”.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-mei-2016
- Target number of participants14
- InterventionsThoracic epidural anaesthesia
Exercise bicycle/stress testing
- Primary outcomeTo evaluate the HTEA effects on systolic and diastolic cardiac function in rest and after different levels of exercise. Echocardiographic variables: MV E, MV DT, MV A, MV E/A, MV S', MV A', MV E', TV E, TV A, TV E/A, TV S', TAPSE
- Secondary outcomeTo assess the difference in hemodynamic response between bicycling with and without thoracic epidural anaesthesia.
Variables:
HR,automated ST segment analysis by 5-lead ECG, invasive blood pressure, CO by Vigileo system
- TimepointsEighteen patients scheduled for thoracic surgery (full lateral thoracotomies or pleurodesis by video-assisted thoracoscopic surgery/VATS) under thoracic epidural anaesthesia (TEA) and general anaesthesia will be assigned randomly to one of the two study arms. The randomization will be performed using a computer generating a randomization list. After epidural administration of either NaCl 0,9 % or ropivacaine 0.75 % patients will perform an exercise test on a bicycle. Each patient will perform this exercise test at two different time periods:

Test period 1: Day before surgery. Test period 2: Immediately before surgery.

In study arm A, the patient will receive an epidural dose of 6 ml of NaCl 0.9 % in period 1 and 6 ml of ropivacaine 0.75 % in period 2. In study arm B patients receive an epidural dose 6 ml of ropivacaine 0.75 % in period 1 and 6 ml of NaCl 0.9% in period 2. Patient and investigators will not be blinded to the epidural study medication.
T0 baseline = before epidural injection of ropivacaine/NaCl
T1 epidural = 30 minutes after epidural injection of ropivacaine/NaCl
T2 exercise = after 3 minutes bicycling with 20 % of maximal workload
T3 exercise = after 3 minutes bicycling with 40 % of maximal workload
T4 exercise = after 3 minutes bicycling with 60 % of maximal workload
T5 recovery = after 10 minutes recovery of exercise test
- Trial web site
- statusstopped
- 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 summaryThere are several studies on the effect of thoracic epidural anaesthesia on left ventricular (LV) function, but the results are controversial 5, 6, 7, 8. These studies were performed in baseline conditions, where cardiac sympathicotonus is low and sympathicolysis by TEA might not be that influential. The influence of upper TEA on circulation during physical exercise has already been tested 9, 10, but these studies used questionable study designs (repeated exercise tests) and the executed echocardiographic exam was very limited. Furthermore, the influence of upper TEA on the performance of the right ventricle (RV) under physical exercise has not been evaluated. Recently, Rex and colleagues 11 demonstrated that in pigs TEA strongly inhibited the positive inotropic response of the RV to acute pulmonary hypertension, suggesting an important role for sympathetic nervous system. Reason for us to conduct a study that non-invasively evaluates the effects of TEA on biventricular systolic and diastolic function during exercise by using pulsed wave tissue Doppler imaging. We hypothesize that the circulatory and cardiac effects of TEA will be most pronounced during circumstances of increased sympathicotonus, which will be induced by an exercise test on a bicycle.
- Main changes (audit trail)
- RECORD6-nov-2014 - 1-okt-2017


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