About this trial
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.
Eligibility criteria
Qualifiers
are between 18 and 85 years old
have a clinical diagnosis of AIS due to anterior circulation large artery occlusion (including internal carotid artery or/and middle cerebral artery)
with a score on the National Institute of Health Stroke Scale (NIHSS) ≥10 before surgery
with a modified Rankin scale (mRS) <3 before stroke
Disqualifiers
previous intracranial hemorrhage within 6 weeks
vascular stents implantation in the responsible blood vessel
Glasgow score ≤8 points before surgery
known allergy to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, stainless steel, and allergy or contraindication to contrast agent
Trial design
Treatments tested in this trial
- post-operative sedation
- routine recovery
Treatment groups
Sponsors and collaborators
RenJi Hospital
Lead sponsor
Changhai Hospital
Collaborator
Huashan Hospital
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Beijing Chao Yang Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Tongji University
Collaborator
Henan Provincial People's Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Fujian Provincial Hospital
Collaborator
The First People's Hospital of Lianyungang
Collaborator
The Affiliated Hospital of Ningbo University
Collaborator