Acute ischemic stroke
Conditions
Interventions
dexmedetomidine:conscious sedation with dexmedetomidine
midazolam:conscious sedation with midazolam
Sponsors
General Hospital of Eastern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1: Age =18 years 2: Presenting with symptoms of acute ischemic stroke 3: CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery) 4: Randomization finished within 24 hours of symptom onset or time last know well 5: Pre-stroke mRS score =2 6: NIHSS score =6 at the time of randomization 7: ASPECTS value =3 8: Informed consent signed
Exclusion criteria
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 componennts 5: Planned to receive general anesthesia for EVT 6: Uncontrolled hypertension or hypotension (defined as systolic blood pressure >185 mmHg or 110 mmHg or 50 s or international normalized ratio > 1.7) 10: Blood glucose 22.2 mmol/L 11: Severe renal insufficiency (defined as glomerular filtration rate 220 mmol/L (2.5mg/dl)) 12: Receiving hemodialysis or peritoneal dialysis 13: Life expectancy less than 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 19: Evidence of intracranial hemorrhage on CT or MRI 20: Cerebellar infarction with obvious space-occupying effects and fourth ventricle compression on CT or MRI 21: Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation 22: Bilateral occlusion or multiple intracranial vessels occlusions 23: Intracranial tumors (with mass effect)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of favorable neurological function at 90 days;Recanalization rate at 24-72 hours after EVT, assessed with CTA/MRA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Shift in the distribution of mRS scores at 90 days;Proportion of mRS score 0 to 1 at 90 days;Proportion of mRS score 0 to 3 at 90 days;Proportion of successful recanlization immediate after EVT;The change of the ASPECTS score at 24-72 hours from baseline;Final infarct volume at 24-72 hours after EVT and will be compared with infarct volume at baseline;Degree of sedation score during procedure;The change of the GCS score at 24 hours from baseline;The change of the NIHSS score at 24 hours from baseline;The change of the GCS score at 5-7 days or discharge from baseline;The change of the NIHSS score at 5-7 days or discharge from baseline;European Quality Five Dimensions (EQ-5D) scale score at 90 days;Barthel Index at 90 days; | — |
Countries
China
Contacts
Public ContactRui Liu
General Hospital of Eastern Theater Command
Outcome results
None listed