Comparing sedation methods during endovascular thrombectomy for stroke patients

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

This study is testing whether using midazolam or dexmedetomidine for sedation during a procedure to remove a blood clot can help stroke patients recover better after 90 days.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 810 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Locations: 2 sites (Nanjing, None Selected and 1 other locations)
• Trial ID: NCT06139692 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized clinical trial evaluates the safety and efficacy of two sedation methods, midazolam and dexmedetomidine, during endovascular thrombectomy in patients with acute ischemic stroke caused by large vessel occlusion. Participants will be randomly assigned to one of the two sedation groups within 24 hours of symptom onset. The primary endpoint is the proportion of patients achieving a modified Ranking score of 0-2 at 90 days post-procedure, which indicates favorable functional outcomes. The study aims to provide insights that could enhance clinical practices in treating acute ischemic stroke.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older presenting with acute ischemic stroke symptoms and confirmed large vessel occlusion in the anterior circulation.

Not a fit: Patients who are pregnant, have known allergies to the sedation medications, or require general anesthesia for the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve sedation practices during endovascular thrombectomy, leading to better patient outcomes in acute ischemic stroke treatment.

How similar studies have performed: While there is ongoing research in sedation methods for endovascular procedures, this specific comparison of midazolam and dexmedetomidine in acute ischemic stroke is novel and has not been extensively tested.

Eligibility 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:

General 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. Planned to receive general anesthesia for EVT
6. Uncontrolled hypertension or hypotension (defined as systolic blood pressure \>185 mmHg or \< 90 mmHg, diastolic blood pressure \>110 mmHg or \< 60 mmHg)
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\\\*109 /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 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 Imaging exclusion criteria

1\. 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)

Where this trial is running

Nanjing, None Selected and 1 other locations

• Jinling Hospital, Medical School of Nanjing University — Nanjing, None Selected, China (Recruiting)
• The General Hospital of Western Theater Command PLA — Chengdu, China (Recruiting)

Study contacts

• Principal investigator: Xinfeng Liu — Department of Neurology, Jinling Hospital, China
• Study coordinator: Rui Liu

Conditions Acute Ischemic Stroke