Effects of Post-Operative Sedation for Endovascular Thrombectomy

Summary

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.

Conditions

• Acute Ischemic Stroke
• Endovascular Thrombectomy

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

• Changhai Hospital

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Shanghai Tongji Hospital, Tongji University School of Medicine

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Tongji University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• The Affiliated Hospital of Ningbo University

  collaborator UNKNOWN

• RenJi Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-24

Primary Completion

2025-12-30

Completion

2025-12-30

Countries

• China

Study Locations