Actively Recruiting
Effects of Post-Operative Sedation for Endovascular Thrombectomy
Led by RenJi Hospital · Updated on 2024-07-03
1286
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
C
Changhai Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Post-Operative Sedation for Endovascular Thrombectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are between 18 and 85 years old
- Have a clinical diagnosis of acute ischemic stroke due to anterior circulation large artery occlusion (internal carotid artery and/or middle cerebral artery)
- Have a National Institute of Health Stroke Scale (NIHSS) score of 10 or higher before surgery
- Have a modified Rankin scale (mRS) less than 3 before stroke
- Underwent endovascular thrombectomy under general anesthesia and achieved successful reperfusion (mTICI 2b-3) confirmed by digital subtraction angiography at surgery end
- Provided informed consent by patient or legal representative
You will not qualify if you...
- Previous intracranial hemorrhage within 6 weeks
- Vascular stent implantation in the responsible blood vessel
- Glasgow Coma Scale score 8 or lower before surgery
- Known allergy to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, stainless steel, or contrast agents
- Contraindication to dexmedetomidine
- Known hemoglobin less than 70 g/L, platelet count less than 50 x 10^9/L, INR greater than 1.5, or other uncorrectable bleeding problems
- Severe liver or kidney dysfunction (ALT or AST more than 3 times upper limit of normal, or creatinine more than 1.5 times upper limit)
- Pregnant or breastfeeding
- History of mental illness
- Currently participating in another clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, China, 200126
Actively Recruiting
Research Team
W
Weifeng Yu, Ph.D.
CONTACT
J
Jie Tian, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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