Confusion Clinical Trial
Official title:
Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
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.
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.
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