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出境医 / 临床实验 / Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion (HYPSED)
Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion (HYPSED)
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.
| 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.
Study Design
| 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 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- Incidence of intraoperative complications [ Time Frame: 72 hours ]Intraoperative complications
Other Outcome Measures:
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Marina Rubatti | 0033140948635 | m.rubatti@hml.fr | |
| Contact: Carmen Credico | 0033140948624 | c.credico@hml.fr |
Locations
| 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
| Principal Investigator: | Marina Rubatti | Hôpital Marie Lannelongue |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | ||||||||
| First Posted Date ICMJE | June 4, 2019 | ||||||||
| Last Update Posted Date | January 23, 2020 | ||||||||
| 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 |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Incidence of intraoperative complications [ Time Frame: 72 hours ] Intraoperative complications
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
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| 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. |
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| 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
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| 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Chirurgical Marie Lannelongue | ||||||||
| Study Sponsor ICMJE | Centre Chirurgical Marie Lannelongue | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Centre Chirurgical Marie Lannelongue | ||||||||
| Verification Date | January 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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