Clinical trial NCT03974269: Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion
Official title: Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Confusion
Keywords: Hypnosis
Delirium
Transcatheter aortic valve implantation
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms : hypnosis group and sedation group
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Occurrence of a postoperative delirium episode
timeFrame: 72 hours
Secondary outcomes:
measure: Incidence of intraoperative complications
timeFrame: 72 hours
Other outcomes:
measure: Length of the procedures
timeFrame: 72 hours
measure: Comfort felt by the patient
timeFrame: 72 hours
measure: Operator comfort
timeFrame: 72 hours
measure: Anxiety assessment
timeFrame: 72 hours
measure: Patient pain
timeFrame: 72 hours
measure: episodes of nausea and vomiting at the 1st meal after the procedure
timeFrame: 72 hours
measure: Patient satisfaction at the end of the procedure
timeFrame: 72 hours
measure: Incidence of anesthetic procedure in both groups:
timeFrame: 72 hours
measure: Average lengths of stay,
timeFrame: 72 hours
measure: Incidence of mortality during the hospital stay
timeFrame: 72 hours
measure: Costs of hospital stays.
timeFrame: 72 hours
Locations:
city: Le Plessis-Robinson
country: France
facility: Hopital Marie Lannelongue
Study officials:
affiliation: Hôpital Marie Lannelongue
name: Marina Rubatti
role: PRINCIPAL_INVESTIGATOR
References: