Dexmedetomidine: Patients receive perioperative sedation with dexmedetomidine
Midazolam: Patients receive perioperative sedation with midazolam
Study summary
This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1. Age ≥ 18 years;
2. Presenting with symptoms of acute ischemic stroke within 24 hours of last known well;
3. Computed tomography angiography or magnetic resonance angiography confirmed occlusion of the intracranial segment of the internal carotid artery, M1 or M2 segment of the middle cerebral artery;
4. Pre-stroke modified Rankin scale (mRS) score ≤ 2;
5. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 before randomization;
6. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3 prior to randomization;
7. The patient or their legal representative provides written informed consent.
Exclusion criteria
1. Pregnant or lactating women;
2. Known allergy to contrast agents or nitinol devices;
3. Known allergy to midazolam or other benzodiazepines;
4. Known allergy to dexmedetomidine or its components;
5. Long-term use of sedative medications, α2-adrenergic receptor agonists (such as clonidine), or potent CYP450 inhibitors or inducers before randomization;
6. Uncontrolled hypertension or hypotension (defined as systolic blood pressure \> 185 mmHg or \< 90 mmHg, diastolic blood pressure \> 110 mmHg or \< 60 mmHg) measured prior to randomization;
7. Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats / min;
8. Any major surgery or serious trauma within 14 days;
9. Known genetic or acquired bleeding diathesis (platelet count \< 100\*10\^9/L, activated partial thromboplastin time \> 50 s or international normalized ratio \> 1.7);
10. Blood glucose \< 2.8 or \> 22.2 mmol/L;
11. Severe renal insufficiency (defined as glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 mmol/L \[2.5mg/dl\]);
12. Receiving hemodialysis or peritoneal dialysis;
13. Life expectancy ≤ 1 year;
14. Severe agitation or seizures;
15. Clinical manifestations of central nervous system vasculitis;
16. Premorbid neurological disease or mental disorders confounding evaluation;
17. Unwilling to be followed up within 90 days;
18. Participation in other interventional randomized clinical trials.
Imaging exclusion criteria
1. Evidence of intracranial hemorrhage on computed tomography (CT) or magnetic resonance imaging (MRI);
2. Cerebellar infarction with obvious space-occupying effects and fourth ventricle compression on CT or MRI;
3. Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation;
4. Bilateral occlusion or multiple intracranial vessels occlusions;
5. Intracranial tumors (with mass effect).
Primary outcome measure(s)
The proportion of mRS score 0-2 at 90 days — 90 days after randomization mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Trial sites (4)
Facility
City
Region
Status
Yijishan Hospital of Wannan Medical College
Wuhu
Anhui
Jinling Hospital, Medical School of Nanjing University
Nanjing
None Selected
Liaocheng Third hsopital
Liaocheng
Shandong
The General Hospital of Western Theater Command PLA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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