Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion (HYPSED)

Centre Chirurgical Marie Lannelongue

Status

Unknown

Conditions

Confusion

Treatments

Procedure: TAVI : Transcatether Aortic Valve Implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT03974269

2018-A00563-52

Details and patient eligibility

About

TAVI has become a credible alternative to conventional cardiac surgery in aged high-risk patients with aortic valve stenosis. A large part of these procedures are performed with sedation using remifentanil target-controlled infusion plus local anesthesia. However, a significant proportion of the patients experience postoperative delirium, with subsequent worsened outcomes, time-consuming interventions, and increased costs. The use of hypnosis before and during TAVI could decrease the incidence of postoperative delirium thanks to less opioids and hypnotics consumption. Thus, the investigators ought to evaluate the potential advantages of hypnosis vs. remifentanil target controlled-infusion during TAVI procedures.

Full description

Each included patient will randomly be assigned either to the hypnosis group or to the remifentanil group. Patients of the hypnosis group will have one preoperative and one perioperative hypnosis session with a qualified anesthesiologist. Patients of the remifentanil group will receive sedation with remifentanil, administered using a pre specified target controlled-infusion protocol.

Incidence of delirium will be recorded in the cardiac intensive care unit (CICU) during the first 72 postoperative hours, using the Confusion Assessment Method in the ICU (CAM-ICU). Incidence of other complications such as episodes of oxygen desaturation, vascular wound, stroke, general anesthesia requirement and inhospital death will be recorded, as well as procedure duration, hospital length of stay, patient satisfaction and operator comfort.

Transcatheter aortic valve implantation (TAVI) procedures are frequently complicated with postoperative delirium.

Enrollment

186 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups, including a placebo group

Hypnosis arm

Active Comparator group

Description:

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.

Treatment:

Procedure: TAVI : Transcatether Aortic Valve Implantation

Sedation arm

Placebo Comparator group

Description:

Treatment:

Procedure: TAVI : Transcatether Aortic Valve Implantation