Near INfrared Spectroscopy in Aortic valvE ReplacemenT (INSERT)

German Heart Center Munich

Status: Completed

Conditions: Transcatheter Aortic Valve Implantation; Aortic Valve Stenosis; Eligibility for Both Anaesthetic Methods

Treatments: Procedure: Sedation; Procedure: General anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01251328

GE DHM-AN-OR-2010/01

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• informed consent
• transcatheter aortic valve implantation

Exclusion criteria

• denial by patient
• denial by screening anaesthesist
• active neurodegenerative disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

General anaesthesia

Active Comparator group

Description:

General anaesthesia is performed under standardized conditions

Treatment:

Procedure: General anaesthesia

Sedation

Active Comparator group

Description:

Sedation is performed under standardized conditions

Treatment:

Procedure: Sedation