Trials / Completed
CompletedNCT01251328
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
Near Infrared Spectroscopy in Aortic Valve Replacement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Deutsches Herzzentrum Muenchen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Aortic Valve Stenosis
- Transcatheter Aortic Valve Implantation
- Eligibility for Both Anaesthetic Methods
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | General anaesthesia | general anaesthesia is performed according to the hospitals standard |
| PROCEDURE | Sedation | Sedation is performed according to the hospitals standard |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2010-12-01
- Last updated
- 2015-02-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01251328. Inclusion in this directory is not an endorsement.