Aortic Valve Stenosis, Eligibility for Both Anaesthetic Methods, Transcatheter Aortic Valve Implantation
Conditions
Brief summary
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods. This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the rapid pacing-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.
Interventions
PROCEDUREGeneral anaesthesia
general anaesthesia is performed according to the hospitals standard
PROCEDURESedation
Sedation is performed according to the hospitals standard
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed consent * transcatheter aortic valve implantation
Exclusion criteria
* denial by patient * denial by screening anaesthesist * active neurodegenerative disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oxygen desaturation during the rapid pacing period and periprocedural | up to 48 hours | Biomarkers for cerebral ischemia will be measured up to 48 hours |
Countries
Germany
Outcome results
None listed