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

NCT03974269 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-01-23

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Marina Rubatti · Hôpital Marie Lannelongue

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2020-06-11
Completion
2021-06-11

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974269 on ClinicalTrials.gov