Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-05 @ 4:54 PM
Study NCT ID:
NCT02889718
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia Feasibility Study With the CONCERT-CL® Station
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station', 'timeFrame': 'From start of anesthesia until the release of the patient from recovery room', 'description': 'The evaluation will measure the level of hypnosis during surgery.\n\n=\\> The performance of the closed loop of the CONCERT-CL® station will be evaluated by studying its overall score (GS).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.\n\nThis is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.\n\nSecondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.\n\nThe study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged 18 years old and over\n* Surgery of any type programmed for longer than 1 hour\n* Anesthesia combining three agents: hypnotic, morphine, curare\n\nExclusion Criteria:\n\n* minor patient\n* pregnant and lactating women\n* Known or suspected hypersensitivity to propofol,\n* known or suspected hypersensitivity to remifentanil and other fentanyl derivatives,\n* known or suspected hypersensitivity to rocuronium and atracurium, preventing the use of the two products.\n* peanut allergy, soy, Egg\n* neurological disease history with known modification of the electroencephalogram\n* severe eye disease, ocular implant, standing diabetes with diabetic retinopathy\n* gravis\n* pacemakers patient\n* surgery whose position is not suitable for a monitoring on the ulnar nave\n* general anesthesia associated with regional anesthesia\n* Simultaneous use of shortwave therapy or microwave\n* Simultaneous use of high frequency surgical apparatus\n* 15 patients under supervision or unable to consent\n* patient undergoing psychiatric care\n* patient in a health or social institution\n* emergency'}, 'identificationModule': {'nctId': 'NCT02889718', 'acronym': 'CONCERT', 'briefTitle': 'Anesthesia Feasibility Study With the CONCERT-CL® Station', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer', 'orgStudyIdInfo': {'id': 'ICO-N-2014-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anaesthesia with CONCERT-CL® station', 'description': 'During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station', 'interventionNames': ['Device: CONCERT-CL® station', 'Other: Surgery']}], 'interventions': [{'name': 'CONCERT-CL® station', 'type': 'DEVICE', 'description': 'During cancer surgery (surgery \\> 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents:\n\n* Port B = open loop: Analgesic\n* Port A = closed loop: Hypnotic\n* Port C = closed loop: Curare', 'armGroupLabels': ['anaesthesia with CONCERT-CL® station']}, {'name': 'Surgery', 'type': 'OTHER', 'description': 'Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.', 'armGroupLabels': ['anaesthesia with CONCERT-CL® station']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'ICO', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'MAVOUNGOU Philippe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}