Effects of Post-Operative Sedation for Endovascular Thrombectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorRenJi Hospital

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

1,286 Participants
are divided into 2 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