RecruitingPhase 4NCT06139692

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) A Randomised Multicentre Trial

Sponsor

Jinling Hospital, China

Enrollment

810 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

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

Min Age: 18 Years

Inclusion Criteria8

Age ≥18 years
Presenting with symptoms of acute ischemic stroke
CTA or MRA confirmed occlusion of the anterior circulation (intracranial carotid artery or M1, M2 segment of the middle cerebral artery)
Randomization finished within 24 hours of symptom onset or time last know well
Pre-stroke mRS score ≤2
NIHSS score ≥6 at the time of randomization
ASPECTS value ≥3
Informed consent signed

Exclusion Criteria18

Pregnant or lactating women
Known allergy to contrast agents or nitinol devices
Known allergy to midazolam or other benzodiazepines
Known allergy to dexmedetomidine or its components
Planned to receive general anesthesia for EVT
Uncontrolled hypertension or hypotension (defined as systolic blood pressure >185 mmHg or < 90 mmHg, diastolic blood pressure >110 mmHg or < 60 mmHg)
Second-degree or third-degree heart blockage or bradyarrhythmia with a baseline heart rate lower than 50 beats/min
Any major surgery or serious trauma within 14 days
Known genetic or acquired bleeding diathesis (platelet count < 100\\*109 /L, activated partial thromboplastin time > 50 s or international normalized ratio > 1.7)
Blood glucose <2.8 or > 22.2 mmol/L
Severe renal insufficiency (defined as glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl))
Receiving hemodialysis or peritoneal dialysis
Life expectancy less than 1 year
Severe agitation or seizures
Clinical manifestations of central nervous system vasculitis
Premorbid neurological disease or mental disorders confounding evaluation
Unwilling to be followed up within 90 days
\. Evidence of intracranial hemorrhage on CT or 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)