Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT03517735
Status:
TERMINATED
Last Update Posted:
2021-11-05
First Post:
2018-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Postoperative Sedation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Modification of the device', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate sedation', 'timeFrame': '6 hours', 'description': 'Percentage of time with BIS between 55 and 75 (BIS(55-75))'}], 'secondaryOutcomes': [{'measure': 'Period of too deep sedation', 'timeFrame': '6 hours', 'description': 'Percentage of time with BIS values less than 55'}, {'measure': 'Period of too light sedation', 'timeFrame': '6 hours', 'description': 'Percentage of time with BIS values greater than 75'}, {'measure': 'Incidence of Burst Suppression (bsr) during sedation', 'timeFrame': '6 hours', 'description': 'Presence of Burst Suppression defined by a rate \\> 10% for at least one minute'}, {'measure': 'Level of sedation', 'timeFrame': '6 hours', 'description': 'Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert \\& calm)'}, {'measure': 'Level of pain during sedation', 'timeFrame': '6 hours', 'description': 'Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed :\n\n* Numeric Scale for Facial expression : from 1 (relaxed) to 4 (grimacing)\n* Numeric Scale for Upper limb movements : from 1 (no movement) to 4 (permanently retracted)\n* Numeric Scale for Compliance with mechanical ventilation : from 1 (tolerating movement) to 4 (unable to control ventilation)'}, {'measure': 'Medical interventions', 'timeFrame': '6 hours', 'description': 'Number and causes of transient or permanent interruptions in automated administration'}, {'measure': 'Hemodynamic status during the sedation period', 'timeFrame': '6 hours', 'description': 'Evolution of hemodynamic parameters (composite : arterial blood pressure in mmHg and heart rate in bpm)'}, {'measure': 'Sedation time', 'timeFrame': '6 hours', 'description': 'Duration of sedation'}, {'measure': 'Delay before awakening', 'timeFrame': '6 hours', 'description': 'Delay between the cessation of infusion of propofol and remifentanil and extubation.'}, {'measure': 'Dose of hypnotic drug', 'timeFrame': '6 hours', 'description': 'Total amount of propofol during sedation period'}, {'measure': 'Dose of analgesic drug', 'timeFrame': '6 hours', 'description': 'Total amount of remifentanil during sedation period'}, {'measure': 'Level of consciousness after extubation', 'timeFrame': '9 hours', 'description': 'Richmond Agitation-Sedation Scale : from -5 (unarousable) to +4 (combative); the best value being 0 (alert \\& calm)'}, {'measure': 'Level of pain after extubation', 'timeFrame': '9 hours', 'description': 'Behavioral Pain Scale : from 3 (no pain) to 12 (maximum pain) 3 subscales summed :\n\n* Numeric Scale for Facial expression : from 1 (relaxed) to 4 (grimacing)\n* Numeric Scale for Upper limb movements : from 1 (no movement) to 4 (permanently retracted)\n* Numeric Scale for Compliance with mechanical ventilation : from 1 (tolerating movement) to 4 (unable to control ventilation)'}, {'measure': 'Awareness during the sedation period', 'timeFrame': '48 hours', 'description': 'Awareness standardized questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Sedation', 'Surgery, Cardiac']}, 'referencesModule': {'references': [{'pmid': '21233500', 'type': 'RESULT', 'citation': 'Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.'}, {'pmid': '23223772', 'type': 'RESULT', 'citation': 'Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.', 'detailedDescription': 'Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation.\n\nMedsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor.\n\nAutomated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity.\n\nThis randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac surgical procedure requiring postoperative sedation\n* Low operative risk : EuroSCORE 2 ≤ 5%\n* Consent for participation\n* Affiliation to the social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Neurological or muscular disorder\n* Pacemaker\n* Hypersensitivity to propofol or remifentanil\n* Communication difficulties or neuropsychiatric disorder'}, 'identificationModule': {'nctId': 'NCT03517735', 'acronym': 'SEPOCA', 'briefTitle': 'Automated Postoperative Sedation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation', 'orgStudyIdInfo': {'id': '2017/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automated postoperative sedation', 'description': 'Automated administration of Propofol and Remifentanil.', 'interventionNames': ['Device: EasyTiva (algorithm is the property of Medsteer SAS)', 'Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual postoperative sedation', 'description': 'Manual administration of Propofol and Remifentanil.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}], 'interventions': [{'name': 'EasyTiva (algorithm is the property of Medsteer SAS)', 'type': 'DEVICE', 'description': 'Propofol and Remifentanil are administered automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 55 and 75.', 'armGroupLabels': ['Automated postoperative sedation']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'The dosage is modified automatically by the device or according to the new medical prescription.', 'armGroupLabels': ['Automated postoperative sedation', 'Manual postoperative sedation']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'The dosage is modified automatically by the device or according to the new medical prescription.', 'armGroupLabels': ['Automated postoperative sedation', 'Manual postoperative sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'CMC Ambroise Paré', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}], 'overallOfficials': [{'name': 'Thierry Chazot, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital FOCH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}