Status:
RECRUITING
Effects of Post-Operative Sedation for Endovascular Thrombectomy
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Changhai Hospital
Huashan Hospital
Conditions:
Acute Ischemic Stroke
Endovascular Thrombectomy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 wi...
Detailed Description
Theoretically, general anesthesia (GA) has profound brain protection potential, because it can induce a sedative status in patients, reduce brain tissue metabolism and oxygen consumption, inhibit neur...
Eligibility Criteria
Inclusion
- 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
- 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.
- Informed consent by the patient him-/herself or his/her legal representative
Exclusion
- 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
- contraindication to dexmedetomidine
- known hemoglobin less than 70g/L, platelet count less than 50×109L, international normalized ratio (INR) greater than 1.5, or other uncorrectable bleeding issues
- 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
- are pregnant or breast feeding
- have history of mental illness
- are currently participating in another clinical trial.
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
1286 Patients enrolled
Trial Details
Trial ID
NCT04517383
Start Date
November 24 2021
End Date
December 30 2025
Last Update
July 3 2024
Active Locations (1)
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1
Renji Hospital
Shanghai, China, 200126