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

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ClinicalTrials.gov Identifier: NCT03974269
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Confusion Procedure: TAVI : Transcatether Aortic Valve Implantation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arms : hypnosis group and sedation group
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Prevention
Official Title: Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : June 11, 2020
Estimated Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: 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.
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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Occurrence of a postoperative delirium episode [ Time Frame: 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 :
  1. Incidence of intraoperative complications [ Time Frame: 72 hours ]
    Intraoperative complications


Other Outcome Measures:
  1. Length of the procedures [ Time Frame: 72 hours ]
    Duration of the procedure in the catheterization room.

  2. Comfort felt by the patient [ Time Frame: 72 hours ]
    visual scale : score from 0 to 4: 0 not comfortable at all, 4 very

  3. Operator comfort [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions

  4. Anxiety assessment [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety

  5. Patient pain [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable

  6. episodes of nausea and vomiting at the 1st meal after the procedure [ Time Frame: 72 hours ]
    Number of episodes of nausea and vomiting at the 1st meal after the procedure

  7. Patient satisfaction at the end of the procedure [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 not at all satisfied, 10 very satisfied

  8. Incidence of anesthetic procedure in both groups: [ Time Frame: 72 hours ]

    Number of anesthetic procedure failures in both groups

    • in the group Hypothesis defined by a transition to a SIVOC sedation or a general anesthesia.
    • In the Sedation group defined by a transition to "hypnosis" or "hypnotic accompaniment" or general anesthesia

  9. Average lengths of stay, [ Time Frame: 72 hours ]
    Total length of stay in the patient's hospital

  10. Incidence of mortality during the hospital stay [ Time Frame: 72 hours ]
    Occurrence of a death during the hospital stay

  11. Costs of hospital stays. [ Time Frame: 72 hours ]
    Evaluation of the costs of hospital stays.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974269


Contacts
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Contact: Marina Rubatti 0033140948635 m.rubatti@hml.fr
Contact: Carmen Credico 0033140948624 c.credico@hml.fr

Locations
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France
Hopital Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Contact: Marina Rubatti    0033140948635    m.rubatti@hml.fr   
Contact: Carmen Credico    0033140948624    c.credico@hml.fr   
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
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Principal Investigator: Marina Rubatti Hôpital Marie Lannelongue

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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03974269     History of Changes
Other Study ID Numbers: 2018-A00563-52
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Chirurgical Marie Lannelongue:
Hypnosis
Delirium
Transcatheter aortic valve implantation

Additional relevant MeSH terms:
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Confusion
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents