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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis arm | Active Comparator | 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. |
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| Sedation arm | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVI : Transcatether Aortic Valve Implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a postoperative delirium episode | 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. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative complications | Intraoperative complications | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of the procedures | Duration of the procedure in the catheterization room. | 72 hours |
| Comfort felt by the patient | visual scale : score from 0 to 4: 0 not comfortable at all, 4 very |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Rubatti | Contact | 0033140948635 | m.rubatti@hml.fr | |
| Carmen Credico | Contact | 0033140948624 | c.credico@hml.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marina Rubatti | Hôpital Marie Lannelongue | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
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| ID | Term |
|---|---|
| D003221 | Confusion |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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2 arms : hypnosis group and sedation group
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Open label
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| 72 hours |
| Operator comfort | visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions | 72 hours |
| Anxiety assessment | visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety | 72 hours |
| Patient pain | visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable | 72 hours |
| episodes of nausea and vomiting at the 1st meal after the procedure | Number of episodes of nausea and vomiting at the 1st meal after the procedure | 72 hours |
| Patient satisfaction at the end of the procedure | visual scale : score from 0 to 10: 0 not at all satisfied, 10 very satisfied | 72 hours |
| Incidence of anesthetic procedure in both groups: | Number of anesthetic procedure failures in both groups
| 72 hours |
| Average lengths of stay, | Total length of stay in the patient's hospital | 72 hours |
| Incidence of mortality during the hospital stay | Occurrence of a death during the hospital stay | 72 hours |
| Costs of hospital stays. | Evaluation of the costs of hospital stays. | 72 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |