[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611048":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":60,"collaborators":62,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":41,"enrollmentInfo":80,"targetDuration":41,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":101,"whyStopped":41,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"General anesthesia","EXPERIMENTAL","General anesthesia with intubation and mechanical ventilation:\n\nECG, SpO2 and BP. BP will be measured every 2 minutes Hyperglycemia (\\>180mg\u002FdL) and hypoglycemia (\\\u003C60mg\u002FdL) should be treated (outside of the protocol)\n\nSystolic BP: 150 - 180mmHg with Diastolic BP \\\u003C 105mmHg Norepinephrine tartrate infusion or Nicardipine on a peripheral intravenous line or on a 3-way venous extender, as necessary EtCO2 35 - 45mmHg SpO2 above 94 %. Glycemia as needed\n\nEnd of procedure: Anesthesia will be immediately stopped and extubation should not be delayed. After the intervention, patients are transferred to the post anesthesia care unit and are then admitted to the stroke unit\n\nFirst 24 hours: SBP\\\u003C180mmHg, DBP\\\u003C110mmHg and MAP\\>65mmHg, SpO2 \\> 94 %, temperature \\\u003C 38°C, blood glucose 60 - 180mg\u002FdL. Other aspects of monitoring are not modified by the protocol.\n\n24-48h outside of the protocol: non-contrast brain CT or a brain MRI",[13],"Procedure: General Anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Procedural sedation","Procedural sedation with spontaneous ventilation:\n\nECG, SpO2 and BP. BP will be measured every 2 minutes Hyperglycemia (\\>180mg\u002FdL) and hypoglycemia (\\\u003C60mg\u002FdL) should be treated (outside of the protocol)\n\nSystolic BP: 150 - 180mmHg with Diastolic BP \\\u003C 105mmHg Norepinephrine tartrate infusion or Nicardipine on a peripheral intravenous line or on a 3-way venous extender, as necessary Breathing face mask: EtCO2 and oxygen as necessary SpO2 above 94 %. Glycemia as needed\n\nEnd of procedure: Procedural sedation will be immediately stopped. After the intervention, patients are transferred to the post anesthesia care unit and are then admitted to the stroke unit\n\nFirst 24 hours: SBP\\\u003C180mmHg, DBP\\\u003C110mmHg and MAP\\>65mmHg, SpO2 \\> 94 %, temperature \\\u003C 38°C, blood glucose 60 - 180mg\u002FdL. Other aspects of monitoring are not modified by the protocol.\n\n24-48h outside of the protocol: non-contrast brain CT or a brain MRI",[18],"Procedure: Procedural sedation",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","General Anesthesia","In the general anesthesia (GA) group with tracheal intubation : Clinical target: unarousable state Standard preoxygenation, • Rapid sequence induction of GA will use intravenous Etomidate (0.2-0.3mg\u002FKg) or Ketamine (1-2mg\u002FKg) and Succinylcholine (1mg\u002FKg) or Rocuronium (1.2 mg\u002FKg) • Maintenance of GA will use intravenous Propofol (brain tissue target controlled infusion up to 4.0 µg\u002FmL or up to 5.0 mg\u002Fkg\u002Fhr) or Sevoflurane (end-tidal concentration up to 2% (EtSevo)) and intravenous Remifentanil (brain tissue target controlled infusion up to 4.0 ng\u002FmL) Movement despite unarousable state: NMBA as needed",[9],[26],"GA",{"type":21,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"In the procedural sedation group with spontaneous ventilation :\n\nClinical target: alert and \"confortable\" i.e. minimal to moderate sedation level\n\n* Subcutaneous local anesthesia with Lidocaine 10mg\u002FmL (maximum 10mL)\n* Intravenous Remifentanil as necessary to achieve the sedation clinical target (brain tissue target controlled infusion up to 2.0 ng\u002FmL). Propofol could be added as necessary (brain tissue target controlled infusion up to 3.0 µg\u002FmL or 2.0 mg\u002Fkg\u002Fhr).\n\nThe lightest sedation level allowing the intervention has to be sought.",[15],[31],"PS",[33],{"name":34,"affiliation":5,"role":35},"Russell CHABANNE","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Lise Laclautre","CONTACT","334.73.754.963",null,"promo_interne_drci@chu-clermontferrand.fr",[44],{"facility":45,"status":41,"city":46,"state":41,"zip":41,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CHU de Clermont-Ferrand","Clermont-Ferrand","France","FR",{"type":50,"coordinates":51},"Point",[52,53],3.08682,45.77969,{"lat":53,"lon":52},[56,58],{"name":38,"role":39,"phone":57,"phoneExt":41,"email":42},"0473754963",{"name":59,"role":35,"phone":41,"phoneExt":41,"email":41},"Russell Chabanne",{"type":61,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[63,66,68],{"name":64,"class":65},"PHRC, Ministry of Health France","UNKNOWN",{"name":67,"class":65},"STROKELINK",{"name":69,"class":65},"ANARLF Network","100611048","anesthesia-management-in-endovascular-therapy-for-ischemic-stroke---2-100611048",false,"NCT07235514","Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2","General Anesthesia Versus Procedural Sedation in Endovascular Therapy for Anterior Circulation Large Vessel Occlusion Stroke: A Multicenter Prospective Randomized Trial","AMETIS 2","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute ischemic stroke with an occlusion of the intracranial internal carotid artery and\u002For the proximal middle cerebral artery (M1-M2) with or without association of extracranial occlusion of the cervical internal carotid artery (tandem lesion)\n* Eligible for mechanical thrombectomy according to international guidelines\n* Informed and signed consent of patient, or if he is unable to consent the consent of patient's relative or emergency procedure in the absence of relative\n* National health insurance\n\nExclusion Criteria:\n\n* Coma or altered vigilance defined as a score ≥ 2 on the level of consciousness 1A subscale of the NIHSS\n* Premorbid disability defined as a mRS \\> 2\n* Posterior circulation stroke\n* Associated cerebral hemorrhage\n* Stroke complicating another acute illness or postoperative stroke\n* Emesis at arrival in angiosuite\n* Allergy to anesthetic medication\n* Pregnant or breast-feeding women\n* Adult under the protection of the law","ALL","18 Years",{"count":81,"type":82},958,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel.\n\nThe main question it aims to answer is:\n\n• Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke?\n\nGA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased.\n\nResearchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke.\n\nParticipants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.",[88,89,22,90,91],"Ischemic Stroke","Anterior Cerebral Circulation","Procedural Sedation","Thrombectomy",[93,94,95,96,97,98,99,100],"Ischemic stroke","anterior circulation","mechanical thrombectomy","anesthetic strategy","general anesthesia","procedural sedation","functional outcome","large vessel occlusion stroke","NOT_YET_RECRUITING","2025-11-17",{"date":104,"type":105},"2025-11-19","ACTUAL",{"date":107,"type":82},"2025-12-01",{"date":109,"type":82},"2029-03-01",{"name":5,"class":6},1]