[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432829":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":58,"overallOfficials":37,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":37,"id":95,"slug":37,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":37,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":37,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":77,"whyStopped":37,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Beijing Chao Yang Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"The favorable functional outcome of stroke-related disability rate","Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.","90 ± 14 days after thrombectomy",[14,18,21,24,27,30,34],{"measure":15,"description":16,"timeFrame":17},"Changes of National Institute of Health stroke scale","NIHSS (admission) - NIHSS (24h)","24 ± 6 hours after thrombectomy",{"measure":15,"description":19,"timeFrame":20},"NIHSS (admission) - NIHSS (7day)","on the 7-day or discharged day whichever comes first, up to 30 days",{"measure":22,"description":23,"timeFrame":20},"Changes of ischemic penumbra","The difference of infarct volume between preoperative and 7-day or discharged day",{"measure":25,"description":25,"timeFrame":26},"Length of ICU stay","From the date of admission until discharged from ICU, up to 30 days",{"measure":28,"description":28,"timeFrame":29},"Length of hospital stay","From the date of admission until discharged from hospital, up to 30 days",{"measure":31,"description":32,"timeFrame":33},"adverse events at 90-day after operation","hypotension (systolic blood pressure under 90mmHg), bradycardia (heart rate under 50bpm), hypoxemia (pulse oxygen saturation under 90%), and serious events such as death and life-threatening events","within 90-day after thrombectomy",{"measure":35,"description":36,"timeFrame":33},"mortality rate at 90-day after operation","Death after thrombectomy within 90-day after operation",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.\n\nDexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.\n\nDexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury.\n\nThe investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Intervention group","EXPERIMENTAL","Dexmedetomidine 0.1\\~1.0 μg\u002Fkg\u002Fh for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.",[51],"Drug: Dexmedetomidine prolonged sedation",{"label":53,"type":54,"description":55,"interventionNames":56},"Control group","PLACEBO_COMPARATOR","An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3.",[57],"Drug: 0.9% saline",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":37},"DRUG","Dexmedetomidine prolonged sedation","Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.",[47],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":37},"0.9% saline","An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.",[53],[69],{"name":70,"role":71,"phone":72,"phoneExt":37,"email":73},"Lina Yang","CONTACT","18611635556","Thoth_safin@sina.com",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Beijing ChaoYang Hospital","RECRUITING","Beijing","Beijing Municipality","100020","China","CN",{"type":84,"coordinates":85},"Point",[86,87],116.39723,39.9075,{"lat":87,"lon":86},[90],{"name":70,"role":71,"phone":72,"phoneExt":37,"email":73},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Changwei Wei","Deputy chief physician","100432829",false,"NCT04916197","Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)","Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)","Inclusion Criteria:\n\n* 2≤NIHSS≤25\n* mRS score before stroke was less than 3\n* Acute ischemic stroke (including anterior circulation)\n* mTICI rate 2b or 3\n* According to the 2018 AHA\u002FASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation\n* Informed consent was signed by patient or legal representative\n\nExclusion Criteria:\n\n* Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks\n* Patients who had received stent treatment at the responsible vessel in the past\n* Neurological function was restored at or before angiography\n* Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications\n* Hemoglobin was less than 70g\u002FL, platelet count was less than 50×109\u002FL, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors\n* Blood glucose \\\u003C 2.7 mmol\u002FL or \\> 22.2 mmol\u002FL\n* Severe liver or kidney disfunction, ALT\\>3 times the upper limit of normal value or AST\\>3 times the upper limit of normal value, creatinine\\>1.5 times the upper limit of normal value\n* Pregnant or lactating women\n* Previous history of mental illness\n* Stroke with other acute diseases or postoperative stroke of other operation\n* Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )","ALL","18 Years","80 Years",{"count":105,"type":106},368,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.",[112],"Acute Ischemic Stroke",[114,115,116],"Endovascular thrombectomy","Dexmedetomidine","Modified Rankin Scale","2023-12-19",{"date":119,"type":120},"2023-12-20","ACTUAL",{"date":122,"type":106},"2024-03-01",{"date":124,"type":106},"2026-12",{"name":5,"class":6},1]