Status:
RECRUITING
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation o...
Detailed Description
Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion. Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ische...
Eligibility Criteria
Inclusion
- 2≤NIHSS≤25
- mRS score before stroke was less than 3
- Acute ischemic stroke (including anterior circulation)
- mTICI rate 2b or 3
- According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation
- Informed consent was signed by patient or legal representative
Exclusion
- Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
- Patients who had received stent treatment at the responsible vessel in the past
- Neurological function was restored at or before angiography
- Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications
- Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors
- Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L
- Severe liver or kidney disfunction, ALT\>3 times the upper limit of normal value or AST\>3 times the upper limit of normal value, creatinine\>1.5 times the upper limit of normal value
- Pregnant or lactating women
- Previous history of mental illness
- Stroke with other acute diseases or postoperative stroke of other operation
- Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT04916197
Start Date
March 1 2024
End Date
December 1 2026
Last Update
December 20 2023
Active Locations (1)
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1
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, China, 100020