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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

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE June 11, 2018
Estimated Primary Completion Date June 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
Incidence of intraoperative complications [ Time Frame: 72 hours ]
Intraoperative complications
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2019)
  • Length of the procedures [ Time Frame: 72 hours ]
    Duration of the procedure in the catheterization room.
  • Comfort felt by the patient [ Time Frame: 72 hours ]
    visual scale : score from 0 to 4: 0 not comfortable at all, 4 very
  • Operator comfort [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions
  • Anxiety assessment [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety
  • Patient pain [ Time Frame: 72 hours ]
    visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable
  • 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
  • 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
  • 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
  • Average lengths of stay, [ Time Frame: 72 hours ]
    Total length of stay in the patient's hospital
  • Incidence of mortality during the hospital stay [ Time Frame: 72 hours ]
    Occurrence of a death during the hospital stay
  • Costs of hospital stays. [ Time Frame: 72 hours ]
    Evaluation of the costs of hospital stays.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion
Official Title  ICMJE Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Confusion
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: TAVI : Transcatether Aortic Valve Implantation
  • 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.
    Intervention: Procedure: TAVI : Transcatether Aortic Valve Implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
186
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 11, 2021
Estimated Primary Completion Date June 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marina Rubatti 0033140948635 m.rubatti@hml.fr
Contact: Carmen Credico 0033140948624 c.credico@hml.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974269
Other Study ID Numbers  ICMJE 2018-A00563-52
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Chirurgical Marie Lannelongue
Study Sponsor  ICMJE Centre Chirurgical Marie Lannelongue
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marina Rubatti Hôpital Marie Lannelongue
PRS Account Centre Chirurgical Marie Lannelongue
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP