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

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (NCT06139692) is a Phase 4 interventional studying Acute Ischemic Stroke, sponsored by Jinling Hospital, China. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 810 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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. willing to sign a consent form signed Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

Dexmedetomidine

Patients receive perioperative sedation with dexmedetomidine

DRUG

Midazolam

Patients receive perioperative sedation with midazolam

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jinling Hospital, Medical School of Nanjing University

Nanjing, None Selected, China

The General Hospital of Western Theater Command PLA

Chengdu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06139692), the sponsor (Jinling Hospital, China), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06139692 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06139692?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06139692?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06139692. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06139692. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.