[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526818":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":73,"studyPopulation":69,"armGroups":74,"interventions":87,"overallOfficials":97,"centralContacts":102,"locations":110,"responsibleParty":141,"collaborators":69,"id":143,"slug":69,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":144,"sex":150,"minAge":151,"maxAge":69,"enrollmentInfo":152,"targetDuration":69,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":69,"overallStatus":113,"whyStopped":69,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Jinling Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"The proportion of mRS score 0-2 at 90 days","mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).","90 days after randomization",[14,16,18,20,24,28,32,35,39,42,45,47],{"measure":15,"description":11,"timeFrame":12},"Shift in the distribution of mRS scores at 90 days",{"measure":17,"description":11,"timeFrame":12},"The proportion of mRS score 0-1 at 90 days",{"measure":19,"description":11,"timeFrame":12},"The proportion of mRS score 0-3 at 90 days",{"measure":21,"description":22,"timeFrame":23},"Rates of successful recanalization","Successful recanalization is defined as mTICI≥2b. mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).","Immediately after the thrombectomy procedure is completed",{"measure":25,"description":26,"timeFrame":27},"Score on the ASPECTS at 24-72 hours","ASPECTS is short for Alberta Stroke Program Early CT Score (ranging from 0 to 10, with a higher score indicating a better perfusion state).","24-72 hours after randomization",{"measure":29,"description":30,"timeFrame":31},"RASS score ≤ -3 during procedure","Deep sedation defined as RASS score ≤ -3. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).","During operation",{"measure":33,"description":34,"timeFrame":31},"RASS score ≤ 0 during procedure","Under sedation defined as RASS score ≤ 0. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).",{"measure":36,"description":37,"timeFrame":38},"Changes of the GCS score at 24 hours","GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).","24 hours after randomization",{"measure":40,"description":41,"timeFrame":38},"Changes of the NIHSS score at 24 hours","NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).",{"measure":43,"description":37,"timeFrame":44},"Changes of the GCS score at 5-7 days","5-7 days after randomization",{"measure":46,"description":41,"timeFrame":44},"Changes of the NIHSS score at 5-7 days",{"measure":48,"description":49,"timeFrame":12},"Barthel Index at 90 days","Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)",[51,55,59,61,63],{"measure":52,"description":53,"timeFrame":54},"Rates of symptomatic intracranial hemorrhage at 48 hours","Clinical safety endpoint. Intracranial hemorrhage within 48 hours on CT\u002FMRI according to Heidelberg bleeding classification.","48 hours after randomization",{"measure":56,"description":57,"timeFrame":58},"Rates of procedure-related complications","Clinical safety endpoint","within 90 days from randomization",{"measure":60,"description":57,"timeFrame":58},"Rates of mortality at 90 days",{"measure":62,"description":57,"timeFrame":58},"Rates of adverse events",{"measure":64,"description":57,"timeFrame":65},"Rates of severe adverse events","with 90 days from randomization",{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":69,"timePerspective":69,"maskingInfo":71},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":72,"maskingDescription":69,"whoMasked":69},"NONE","In the perioperative period of endovascular thrombectomy, the main sedation options are midazolam (MDZ) and dexmedetomidine (DEX). Research has shown that both sedation methods have their advantages and disadvantages, and there is no consensus on how to choose between them. Therefore, this study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy (EVT) in AIS patients with large vessel occlusion in the anterior circulation and hopes to contribute to the advancement of EVT in clinical practice.\n\nIn this trial, acute ischemic stroke patients with large vessel occlusion in the anterior circulation within 24 hours of symptom onset or last known well will be included. In the screening stage, participants who meet the inclusion criteria of the trial, upon completion of screening\u002Fbaseline assessment and after signing the informed consent, will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the dexmedetomidine and midazolam conscious sedation groups. The primary end point is the proportion of modified Ranking score of 0-2 at 90 days.",[75,81],{"label":76,"type":77,"description":78,"interventionNames":79},"the dexmedetomidine group","EXPERIMENTAL","In the experimental group, dexmedetomidine is used for intraoperative sedation. Dexmedetomidine is prepared as an 8μg\u002Fml intravenous infusion. It begins with an initial loading dose of 1μg\u002Fkg, administered over a period exceeding 10 minutes.If dexmedetomidine fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg\u002F(kg\\*h) and a maintenance dose of 0.3-4mg\u002F(kg\\*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT.",[80],"Drug: Dexmedetomidine",{"label":82,"type":83,"description":84,"interventionNames":85},"the midazolam group","ACTIVE_COMPARATOR","In the control group, midazolam is used for intraoperative sedation. Midazolam is prepared as a 1mg\u002Fml intravenous infusion. It starts with an initial intravenous push of 0.05mg\u002Fkg, followed by a maintenance dose of 0.04-0.2mg\u002Fkg administered intravenously via an infusion pump. If midazolam fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg\u002F(kg\\*h) and a maintenance dose of 0.3-4mg\u002F(kg\\*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT.",[86],"Drug: Midazolam",[88,93],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":69},"DRUG","Dexmedetomidine","Patients receive perioperative sedation with dexmedetomidine",[76],{"type":89,"name":94,"description":95,"armGroupLabels":96,"otherNames":69},"Midazolam","Patients receive perioperative sedation with midazolam",[82],[98],{"name":99,"affiliation":100,"role":101},"Xinfeng Liu","Department of Neurology, Jinling Hospital, China","PRINCIPAL_INVESTIGATOR",[103,108],{"name":104,"role":105,"phone":106,"phoneExt":69,"email":107},"Rui Liu","CONTACT","+86 2584801861","liurui8616@163.com",{"name":99,"role":105,"phone":106,"phoneExt":69,"email":109},"xfliu2@vip.163.com",[111,128],{"facility":112,"status":113,"city":114,"state":115,"zip":69,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Jinling Hospital, Medical School of Nanjing University","RECRUITING","Nanjing","None Selected","China","CN",{"type":119,"coordinates":120},"Point",[121,122],118.77778,32.06167,{"lat":122,"lon":121},[125,127],{"name":104,"role":105,"phone":126,"phoneExt":69,"email":107},"+862584801861",{"name":99,"role":105,"phone":126,"phoneExt":69,"email":109},{"facility":129,"status":113,"city":130,"state":69,"zip":69,"country":116,"countryCode":117,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"The General Hospital of Western Theater Command PLA","Chengdu",{"type":119,"coordinates":132},[133,134],104.06667,30.66667,{"lat":134,"lon":133},[137],{"name":138,"role":105,"phone":139,"phoneExt":69,"email":140},"Yao Huang","+86-18608398843","m15928868662@163.com",{"type":101,"investigatorFullName":99,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":69,"oldOrganization":69},"Professor","100526818",false,"NCT06139692","Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke","Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) A Randomised Multicentre Trial","PEACE","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Presenting with symptoms of acute ischemic stroke\n3. CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery)\n4. Randomization finished within 24 hours of symptom onset or time last know well\n5. Pre-stroke mRS score ≤2\n6. NIHSS score ≥6 at the time of randomization\n7. ASPECTS value ≥3\n8. Informed consent signed\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n1. Pregnant or lactating women\n2. Known allergy to contrast agents or nitinol devices\n3. Known allergy to midazolam or other benzodiazepines\n4. Known allergy to dexmedetomidine or its components\n5. Planned to receive general anesthesia for EVT\n6. Uncontrolled hypertension or hypotension (defined as systolic blood pressure \\>185 mmHg or \\\u003C 90 mmHg, diastolic blood pressure \\>110 mmHg or \\\u003C 60 mmHg)\n7. Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats\u002Fmin\n8. Any major surgery or serious trauma within 14 days\n9. Known genetic or acquired bleeding diathesis (platelet count \\\u003C 100\\\\\\*109 \u002FL, activated partial thromboplastin time \\> 50 s or international normalized ratio \\> 1.7)\n10. Blood glucose \\\u003C2.8 or \\> 22.2 mmol\u002FL\n11. Severe renal insufficiency (defined as glomerular filtration rate \\\u003C30 ml\u002Fmin or serum creatinine \\>220 mmol\u002FL (2.5mg\u002Fdl))\n12. Receiving hemodialysis or peritoneal dialysis\n13. Life expectancy less than 1 year\n14. Severe agitation or seizures\n15. Clinical manifestations of central nervous system vasculitis\n16. Premorbid neurological disease or mental disorders confounding evaluation\n17. Unwilling to be followed up within 90 days\n18. Participation in other interventional randomized clinical trials Imaging exclusion criteria\n\n1\\. Evidence of intracranial hemorrhage on CT or MRI 2. Cerebellar infarction with obvious space-occupying effects and fourth ventricle compression on CT or MRI 3. Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation 4. Bilateral occlusion or multiple intracranial vessels occlusions 5. Intracranial tumors (with mass effect)","ALL","18 Years",{"count":153,"type":154},810,"ESTIMATED","INTERVENTIONAL",[157],"PHASE4","This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.",[160],"Acute Ischemic Stroke","2025-11-16",{"date":163,"type":164},"2025-11-18","ACTUAL",{"date":166,"type":164},"2023-11-21",{"date":168,"type":154},"2026-06-13",{"name":5,"class":6},2]