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

Primary Purpose

Confusion

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TAVI : Transcatether Aortic Valve Implantation
Sponsored by
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Confusion focused on measuring Hypnosis, Delirium, Transcatheter aortic valve implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Marie LannelongueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypnosis arm

Sedation arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of intraoperative complications
Intraoperative complications

Full Information

First Posted
April 23, 2019
Last Updated
January 21, 2020
Sponsor
Centre Chirurgical Marie Lannelongue
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1. Study Identification

Unique Protocol Identification Number
NCT03974269
Brief Title
Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion
Acronym
HYPSED
Official Title
Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
June 11, 2020 (Anticipated)
Study Completion Date
June 11, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Confusion
Keywords
Hypnosis, Delirium, Transcatheter aortic valve implantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arms : hypnosis group and sedation group
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sedation arm
Arm Type
Placebo Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
TAVI : Transcatether Aortic Valve Implantation
Intervention Description
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 Measure Information:
Title
Occurrence of a postoperative delirium episode
Description
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.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Incidence of intraoperative complications
Description
Intraoperative complications
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Length of the procedures
Description
Duration of the procedure in the catheterization room.
Time Frame
72 hours
Title
Comfort felt by the patient
Description
visual scale : score from 0 to 4: 0 not comfortable at all, 4 very
Time Frame
72 hours
Title
Operator comfort
Description
visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions
Time Frame
72 hours
Title
Anxiety assessment
Description
visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety
Time Frame
72 hours
Title
Patient pain
Description
visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable
Time Frame
72 hours
Title
episodes of nausea and vomiting at the 1st meal after the procedure
Description
Number of episodes of nausea and vomiting at the 1st meal after the procedure
Time Frame
72 hours
Title
Patient satisfaction at the end of the procedure
Description
visual scale : score from 0 to 10: 0 not at all satisfied, 10 very satisfied
Time Frame
72 hours
Title
Incidence of anesthetic procedure in both groups:
Description
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
Time Frame
72 hours
Title
Average lengths of stay,
Description
Total length of stay in the patient's hospital
Time Frame
72 hours
Title
Incidence of mortality during the hospital stay
Description
Occurrence of a death during the hospital stay
Time Frame
72 hours
Title
Costs of hospital stays.
Description
Evaluation of the costs of hospital stays.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Rubatti
Phone
0033140948635
Email
m.rubatti@hml.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Credico
Phone
0033140948624
Email
c.credico@hml.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Rubatti
Organizational Affiliation
Hôpital Marie Lannelongue
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Marie Lannelongue
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Rubatti
Phone
0033140948635
Email
m.rubatti@hml.fr
First Name & Middle Initial & Last Name & Degree
Carmen Credico
Phone
0033140948624
Email
c.credico@hml.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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