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

Phase

N/A

Condition

Dementia

Treatment

N/A

Clinical Study ID

NCT03974269

2018-A00563-52

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 thoracotomyprocedure
chronic psychosis, bilateral deafness without hearing aids,
emergency procedure,
inability to communicate (severe dementia, non-French speaker),
declined participation

Study Design

June 11, 2018

June 11, 2021

Study 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.

Connect with a study center

Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
France
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.