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

Confusion Clinical Trial

— HYPSED  

Official title:

Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974269
• Other study ID #: 2018-A00563-52
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: June 11, 2021

Study information

• Verified date: January 2020
• Source: Centre Chirurgical Marie Lannelongue
• Contact: Marina Rubatti
• Phone: 0033140948635
• Email: m.rubatti[@]hml.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Confusion
• Consciousness Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Marie Lannelongue	Le Plessis-Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of the procedures	Duration of the procedure in the catheterization room.	72 hours
Other	Comfort felt by the patient	visual scale : score from 0 to 4: 0 not comfortable at all, 4 very	72 hours
Other	Operator comfort	visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions	72 hours
Other	Anxiety assessment	visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety	72 hours
Other	Patient pain	visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable	72 hours
Other	episodes of nausea and vomiting at the 1st meal after the procedure	Number of episodes of nausea and vomiting at the 1st meal after the procedure	72 hours
Other	Patient satisfaction at the end of the procedure	visual scale : score from 0 to 10: 0 not at all satisfied, 10 very satisfied	72 hours
Other	Incidence of anesthetic procedure in both groups:	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	72 hours
Other	Average lengths of stay,	Total length of stay in the patient's hospital	72 hours
Other	Incidence of mortality during the hospital stay	Occurrence of a death during the hospital stay	72 hours
Other	Costs of hospital stays.	Evaluation of the costs of hospital stays.	72 hours
Primary	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.	72 hours
Secondary	Incidence of intraoperative complications	Intraoperative complications	72 hours