[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402217":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":59,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"POS group","EXPERIMENTAL","Patients in the POS group will undergo ET under general anesthesia. After the surgery is done, patients will keep being intubated and mechanically ventilated for 6hrs, during which period the patients will be sedated with sedatives to maintain a BIS value of 50\\~70 and Ramsay sedation score of 5 \\~ 6. The SBP will be controlled between 120 \\~ 180mmHg with vasoactive drugs. After 6hs, the patients will be recovered and extubated.",[13],"Procedure: post-operative sedation",{"label":15,"type":16,"description":17,"interventionNames":18},"Con group","ACTIVE_COMPARATOR","Patients in the Con group will undergo ET under general anesthesia and will be routinely recovered and extubated immediately after the surgery is done. The SBP will be controlled between 120 \\~ 180mmHg with vasoactive drugs for at least 7hrs after the surgery.",[19],"Procedure: routine recovery",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","post-operative sedation","Patients with ischemic stroke will undergo endovascular thrombectomy (ET) under general anesthesia. After the ET surgery is done, patients in POS group will be sedated for 6hrs before extubation.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"routine recovery","Patients with ischemic stroke will undergo endovascular thrombectomy (ET) under general anesthesia. Patients in Con group will be routinely recovered and extubated after the ET surgery is done.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Weifeng Yu, Ph.D.","CONTACT","86-21-68383702","ywf808@yeah.net",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"Jie Tian, Ph.D.","vaseline2001@hotmail.com",[41],{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Renji Hospital","RECRUITING","Shanghai","200126","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":35,"phoneExt":26,"email":39},"Jie Tian, MD, PhD",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[60,62,64,66,68,70,72,74,76,78,80],{"name":61,"class":6},"Changhai Hospital",{"name":63,"class":6},"Huashan Hospital",{"name":65,"class":6},"Shanghai Tongji Hospital, Tongji University School of Medicine",{"name":67,"class":6},"Beijing Chao Yang Hospital",{"name":69,"class":6},"Shanghai 6th People's Hospital",{"name":71,"class":6},"Tongji University",{"name":73,"class":6},"Henan Provincial People's Hospital",{"name":75,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":77,"class":6},"Fujian Provincial Hospital",{"name":79,"class":6},"The First People's Hospital of Lianyungang",{"name":81,"class":82},"The Affiliated Hospital of Ningbo University","UNKNOWN","100402217","effects-of-post-operative-sedation-for-endovascular-thrombectomy-100402217",false,"NCT04517383","Effects of Post-Operative Sedation for Endovascular Thrombectomy","Effects of Post-operative Sedation on Clinical Outcomes in Patients Receiving Endovascular Thrombectomy for Acute Ischemic Stroke","POSET","Inclusion Criteria:\n\n1. are between 18 and 85 years old\n2. have a clinical diagnosis of AIS due to anterior circulation large artery occlusion (including internal carotid artery or\u002Fand middle cerebral artery)\n3. with a score on the National Institute of Health Stroke Scale (NIHSS) ≥10 before surgery\n4. with a modified Rankin scale (mRS) \\\u003C3 before stroke\n5. have endovascular thrombectomy under GA and are confirmed to achieve successful reperfusion (mTICI 2b-3) by digital subtraction angiography (DSA) exam at the end of the operation.\n6. Informed consent by the patient him-\u002Fherself or his\u002Fher legal representative\n\nExclusion Criteria:\n\n1. previous intracranial hemorrhage within 6 weeks\n2. vascular stents implantation in the responsible blood vessel\n3. Glasgow score ≤8 points before surgery\n4. known allergy to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, stainless steel, and allergy or contraindication to contrast agent\n5. contraindication to dexmedetomidine\n6. known hemoglobin less than 70g\u002FL, platelet count less than 50×109L, international normalized ratio (INR) greater than 1.5, or other uncorrectable bleeding issues\n7. severe liver or kidney dysfunction, i.e. ALT or AST \\>3 times the upper limit of normal, or creatinine \\>1.5 times the upper limit of normal\n8. are pregnant or breast feeding\n9. have history of mental illness\n10. are currently participating in another clinical trial.","ALL","18 Years","85 Years",{"count":95,"type":96},1286,"ESTIMATED","INTERVENTIONAL",[99],"NA","Studies from our lab indicated that long-term sedation is protective in mice with midbrain infarct. To assess whether post-operative sedation has protective effects on clinical outcomes in patients with ischemic stroke undergoing endovascular thrombectomy (ET), a multi-center, randomized clinical trial will be carried out (POSET study). In POSET study, patients receiving ET for acute ischemic stroke under general anesthesia will be randomly assigned to the control group (Con group) and the post-operative sedation group (POS group). Patients in the Con group will be recovered and extubated immediately after the surgery, whereas those in the POS group will be sedated with propofol and dexmedetomidine for another 6hrs before extubation. The primary endpoint is the score on the modified Rankin Scale assessed at 90±7 days after randomization. The hypothesis is that patients in the POS group will have improved clinical outcome in 3 months after surgery.",[102,103],"Acute Ischemic Stroke","Endovascular Thrombectomy","2024-07-02",{"date":106,"type":107},"2024-07-03","ACTUAL",{"date":109,"type":107},"2021-11-24",{"date":111,"type":96},"2025-12-30",{"name":5,"class":6},1]