Feasibility and safety of short term application of sevoflurane in patients with SAH treated with aneurysm coiling or clipping in the setting of a neurointensive care unit.
After admission to the ICU, before the coiling / clipping intervention has been performed, the patients are screened for eligibility. When the patients are coming back to the ICU, after successful aneurysm coiling or clipping, data of artificial ventilation, systemic and other cerebral parameters will be collected continuously by online monitoring, starting at baseline and stopping at discharge of the ICU. Sevoflurane will be vaporized and administrated by the MIRUS™System directly to the inspiratory part of the ventilation circuit for the next 4 hours. In the following 14 days of the stay on the ICU, standard monitoring parameters, the appearance of vasospasm and brain oedema will be recorded. Besides the continuous online monitoring, laboratory assessment will be performed daily. At day 7±2 and day 14±2 after bleeding a MRI or CT examination will be performed, according to the clinical condition of the patient, to detect secondary brain injuries, as ischemia or brain oedema. At ICU discharge, the neurological outcome will be assesses applying GOS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Postconditioning with sevoflurane (0.5-1.5vol%) for 4 hours after coiling or clipping of cerebral aneurysm in patients with severe SAH
Before and after postconditioning with sevoflurane the patients will be sedated with intravenous sedatives (midazolam or propofol). The quality of sedation before the postconditioning (propofol or midazolam) will be compared to the sedation one hour after starting the postconditioning (sevoflurane) in the same patient.
Before and after postconditioning with sevoflurane the patients will be sedated with intravenous sedatives (midazolam or propofol). The quality of sedation before the postconditioning (propofol or midazolam) will be compared to the sedation one hour after starting the postconditioning (sevoflurane) in the same patient.
University Hospital Zurich
Zurich, Switzerland
Feasibility: Incidence of concerns/problems in the use of sevoflurane by intensivist and ICU nurse at the stopping of sevoflurane postconditioning.
* Incidence of concerns of users in relation to the application of standard sedation with propofol or midazolam * Incidence of complications with sevoflurane preparation, sevoflurane application, MIRUS™-installation, MIRUS™-function, MIRUS™-removal * User friendliness compared to settings for artificial ventilation supplemented with NO
Time frame: 4 hours
Quality of sedation
* Incidence of insufficient sedation during postconditioning with sevoflurane, measured with: * Ramsay Sedation Scale (RSS \<2) * Richmond Agitation-Sedation Scale (RASS \>0) * Bispectral index (BIS \>30) * Incidence of use of additional sedative medication as midazolam, propofol * in relation to the sedation regimen before and after the postconditioning (dose and use of additional sedative medication as midazolam, propofol)
Time frame: 5 hours
Neuroprotective effects
* Number of days during the 14 days monitoring period with signs of DIND * incidence of new neurological deficits on daily clinical visits * incidence of 2 consecutive metabolic crisis identified by microdialysis, defined as lactate/pyrovate-ratio (L/P-ratio) \>40 * incidence of PtiO2 \<20mmHg at least 60 minutes- immediately before the measurement * incidence of new perfusion deficits in perfusion-CT and/ or -MRI, new infarctions in contrast enhanced CT/ MRI * Neurological outcome (GOS) will be assessed at ICU discharge and compared to data from the literature.
Time frame: 14 days
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The MIRUS™System is the normally used standard equipment for the administration of volatile anaesthetics to patients.