Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT03974269
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2019-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arms : hypnosis group and sedation group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 186}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of the procedures', 'timeFrame': '72 hours', 'description': 'Duration of the procedure in the catheterization room.'}, {'measure': 'Comfort felt by the patient', 'timeFrame': '72 hours', 'description': 'visual scale : score from 0 to 4: 0 not comfortable at all, 4 very'}, {'measure': 'Operator comfort', 'timeFrame': '72 hours', 'description': 'visual scale : score from 0 to 10: 0 bad conditions, 10 excellent conditions'}, {'measure': 'Anxiety assessment', 'timeFrame': '72 hours', 'description': 'visual scale : score from 0 to 10: 0 no anxiety, 10 worst possible anxiety'}, {'measure': 'Patient pain', 'timeFrame': '72 hours', 'description': 'visual scale : score from 0 to 10: 0 no pain, 10 maximum pain imaginable'}, {'measure': 'episodes of nausea and vomiting at the 1st meal after the procedure', 'timeFrame': '72 hours', 'description': 'Number of episodes of nausea and vomiting at the 1st meal after the procedure'}, {'measure': 'Patient satisfaction at the end of the procedure', 'timeFrame': '72 hours', 'description': 'visual scale : score from 0 to 10: 0 not at all satisfied, 10 very satisfied'}, {'measure': 'Incidence of anesthetic procedure in both groups:', 'timeFrame': '72 hours', 'description': 'Number of anesthetic procedure failures in both groups\n\n* in the group Hypothesis defined by a transition to a SIVOC sedation or a general anesthesia.\n* In the Sedation group defined by a transition to "hypnosis" or "hypnotic accompaniment" or general anesthesia'}, {'measure': 'Average lengths of stay,', 'timeFrame': '72 hours', 'description': "Total length of stay in the patient's hospital"}, {'measure': 'Incidence of mortality during the hospital stay', 'timeFrame': '72 hours', 'description': 'Occurrence of a death during the hospital stay'}, {'measure': 'Costs of hospital stays.', 'timeFrame': '72 hours', 'description': 'Evaluation of the costs of hospital stays.'}], 'primaryOutcomes': [{'measure': 'Occurrence of a postoperative delirium episode', 'timeFrame': '72 hours', '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of intraoperative complications', 'timeFrame': '72 hours', 'description': 'Intraoperative complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypnosis', 'Delirium', 'Transcatheter aortic valve implantation'], 'conditions': ['Confusion']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIncidence 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.\n\nTranscatheter aortic valve implantation (TAVI) procedures are frequently complicated with postoperative delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring transfemoral approach TAVI without general anesthesia\n* For adult patients : age greater than or equal to 18 years\n* Patients affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Patient whose age is less than 18 years\n* Approach with general anesthesia\n* Patient not responding to Hypnosis: unmotivated, non-cooperating, not confident\n* Other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure\n* chronic psychosis, bilateral deafness without hearing aids,\n* emergency procedure,\n* inability to communicate (severe dementia, non-French speaker),\n* declined participation'}, 'identificationModule': {'nctId': 'NCT03974269', 'acronym': 'HYPSED', 'briefTitle': 'Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion', 'organization': {'class': 'OTHER', 'fullName': 'Centre Chirurgical Marie Lannelongue'}, 'officialTitle': 'Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion', 'orgStudyIdInfo': {'id': '2018-A00563-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypnosis 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.", 'interventionNames': ['Procedure: TAVI : Transcatether Aortic Valve Implantation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sedation 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.", 'interventionNames': ['Procedure: TAVI : Transcatether Aortic Valve Implantation']}], 'interventions': [{'name': 'TAVI : Transcatether Aortic Valve Implantation', 'type': 'PROCEDURE', '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.", 'armGroupLabels': ['Hypnosis arm', 'Sedation arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marina Rubatti', 'role': 'CONTACT', 'email': 'm.rubatti@hml.fr', 'phone': '0033140948635'}, {'name': 'Carmen Credico', 'role': 'CONTACT', 'email': 'c.credico@hml.fr', 'phone': '0033140948624'}], 'facility': 'Hopital Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}], 'centralContacts': [{'name': 'Marina Rubatti', 'role': 'CONTACT', 'email': 'm.rubatti@hml.fr', 'phone': '0033140948635'}, {'name': 'Carmen Credico', 'role': 'CONTACT', 'email': 'c.credico@hml.fr', 'phone': '0033140948624'}], 'overallOfficials': [{'name': 'Marina Rubatti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Marie Lannelongue'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Chirurgical Marie Lannelongue', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}