Confusion
Conditions
Keywords
Hypnosis, Delirium, Transcatheter aortic valve implantation
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.
Interventions
PROCEDURETAVI : Transcatether Aortic Valve Implantation
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.
Sponsors
Centre Chirurgical Marie Lannelongue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open label
Intervention model description
2 arms : hypnosis group and sedation group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a postoperative delirium episode | 72 hours | Assessment of the level of postoperative confusion will be measured at the CAM-ICU (Confusion Assessment Method Intensive Care Unit) scale. The CAM-ICU scale is a questionnaire based on 4 items. The diagnosis of delirium requires the presence of 3 of the 4 criteria. Criteria 1 and 2 are still required, with criteria 3 or 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative complications | 72 hours | Intraoperative complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operator comfort | 72 hours | visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions |
| Anxiety assessment | 72 hours | visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety |
| Patient pain | 72 hours | visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable |
| episodes of nausea and vomiting at the 1st meal after the procedure | 72 hours | Number of episodes of nausea and vomiting at the 1st meal after the procedure |
| Length of the procedures | 72 hours | Duration of the procedure in the catheterization room. |
| Incidence of anesthetic procedure in both groups: | 72 hours | Number of anesthetic procedure failures in both groups * in the group Hypothesis defined by a transition to a SIVOC sedation or a general anesthesia. * In the Sedation group defined by a transition to hypnosis or hypnotic accompaniment or general anesthesia |
| Average lengths of stay, | 72 hours | Total length of stay in the patient's hospital |
| Incidence of mortality during the hospital stay | 72 hours | Occurrence of a death during the hospital stay |
| Costs of hospital stays. | 72 hours | Evaluation of the costs of hospital stays. |
| Patient satisfaction at the end of the procedure | 72 hours | visual scale : score from 0 to 10: 0 not at all satisfied, 10 very satisfied |
| Comfort felt by the patient | 72 hours | visual scale : score from 0 to 4: 0 not comfortable at all, 4 very |
Countries
France
Contacts
Primary ContactMarina Rubatti
Backup ContactCarmen Credico
Outcome results
None listed