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Xenon versus Desflurane anesthesia during cardioverter defribrillator implantation.


- candidate number9439
- NTR NumberNTR2901
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2011
- Secondary IDs2011/025 MEC UZ Brussel
- Public TitleXenon versus Desflurane anesthesia during cardioverter defribrillator implantation.
- Scientific TitleComparative study between xenon anaesthesia and desflurane anaesthesia in patients with severely decreased left ventricular function, undergoing cardioverter defribrillator implantation.
- ACRONYMN/A
- hypothesisXenon wil provide improved hemodynamics in patients undergoing cardioverter defribrillator implantation.
- Healt Condition(s) or Problem(s) studiedEchocardiography, Defibrillation, Decreased left ventricular function
- Inclusion criteria1. Patients scheduled for internal cardioverter defibrillator implantation;
2. A preoperative left ventricular ejection fraction < .4, as assessed on echocardiography or left ventricular angiography;
3. Age > 17 y;
4. Planned surgery < 2 h.
- Exclusion criteria1. Patients with COPD, myocardial infarction < 3 m before surgery;
2. Withdrawal from the study is performed whenever a serious adverse event (e.g. major bleeding, shock or death) occurs.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate29-feb-2012
- Target number of participants50
- InterventionsXenon versus Desflurane anesthesia monitored by TOE.
- Primary outcomeLV systolic function and contractility will be assessed.
- Secondary outcomePostoperative problems, such as nausea, vomiting, changes of haemodynamics 20 % beyond baseline measurements, or hypoxia will be reported. Also postoperative nausea and vomiting, shivering dizziness, confusion etc. are stated as adverse events.
- TimepointsAfter induction of anesthesia and after hemodynamic stabilisation after the start of the anesthetic.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Poelaert
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryThe study is designed to elucidate the differences in haemodynamics and effects on myocardial function in severely depressed left ventricular function, both in Xenon and Desflurane anesthetised patients undergoing cardioverter defribrillator implantation.
- Main changes (audit trail)
- RECORD17-mei-2011 - 24-mei-2011


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