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

Not Applicable

• Conditions: Confusion

• Registration Number: NCT03974269
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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.

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23
• Primary Completion: 2020-06-11
• Study Completion: 2021-06-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of intraoperative complications	72 hours	Intraoperative complications

Trial Locations

Locations (1)

Hopital Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France