Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion (HYPSED)
Confusion
About this trial
This is an interventional prevention trial for Confusion focused on measuring Hypnosis, Delirium, Transcatheter aortic valve implantation
Eligibility Criteria
Inclusion Criteria:
- Patients requiring transfemoral approach TAVI without general anesthesia
- For adult patients : age greater than or equal to 18 years
- Patients affiliated to a social security scheme
Exclusion Criteria:
- Patient whose age is less than 18 years
- Approach with general anesthesia
- Patient not responding to Hypnosis: unmotivated, non-cooperating, not confident
- Other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure
- chronic psychosis, bilateral deafness without hearing aids,
- emergency procedure,
- inability to communicate (severe dementia, non-French speaker),
- declined participation
Sites / Locations
- Hopital Marie LannelongueRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Hypnosis arm
Sedation arm
TAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least.
TAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least.