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

NCT ID: NCT03974269

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2021-06-11

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.

Conditions

Confusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hypnosis arm

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.

Group Type: ACTIVE_COMPARATOR

TAVI : Transcatether Aortic Valve Implantation

Intervention Type: 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.

Sedation arm

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.

Group Type: PLACEBO_COMPARATOR

TAVI : Transcatether Aortic Valve Implantation

Intervention Type: 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.

Interventions

TAVI : 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Rubatti

Role: PRINCIPAL_INVESTIGATOR

Hôpital Marie Lannelongue

Locations

Hopital Marie Lannelongue

Le Plessis-Robinson, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marina Rubatti

Role: CONTACT

m.rubatti@hml.fr

0033140948635

Carmen Credico

Role: CONTACT

c.credico@hml.fr

0033140948624

Facility Contacts

Marina Rubatti

Role: primary

m.rubatti@hml.fr

0033140948635

Carmen Credico

Role: backup

c.credico@hml.fr

0033140948624

Other Identifiers

2018-A00563-52

Identifier Type: -

Identifier Source: org_study_id