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

NCT03974269 | Unknown

• 1 other identifier: 2018-A00563-52
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Confusion

Keywords

Hypnosis; Delirium; Transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Incidence of intraoperative complications

  72 hours

Other Outcomes (11)

• Length of the procedures

  72 hours

• Comfort felt by the patient

  72 hours

• Operator comfort

  72 hours

Study Arms (2)

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.

Procedure: TAVI : Transcatether Aortic Valve Implantation

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.

Procedure: TAVI : Transcatether Aortic Valve Implantation

Interventions

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.

Hypnosis arm; Sedation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

MeSH Terms

Conditions

Confusion; Delirium

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marina Rubatti

  Hôpital Marie Lannelongue

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Rubatti

CONTACT

0033140948635; m.rubatti@hml.fr

Carmen Credico

CONTACT

0033140948624; c.credico@hml.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms : hypnosis group and sedation group

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: June 4, 2019
• Study Start: June 11, 2018
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)