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Dexmedetomidine versus midazolam for conscious sedation in acute ischemic stroke is plannedTrial plans to compare sedation drugs for stroke patients

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Key Takeaway
Note that this is a protocol; no results are available to inform clinical practice regarding sedation choice.

This randomized controlled trial protocol describes a study involving up to 810 patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (LVO) within 24 hours of the last known well. The study will be conducted across 30 centers in China.

The primary objective is to compare dexmedetomidine (DEX) against midazolam (MDZ) for conscious sedation during endovascular thrombectomy (EVT). The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days. Secondary outcomes include the ordinal distribution of mRS scores at 90 days and successful recanalization.

Safety outcomes include monitoring for symptomatic intracranial hemorrhage within 48 hours and mortality at 90 days. Because this is a protocol, no data regarding results, effect sizes, or adverse event rates are available. The study aims to provide evidence to guide clinical practice regarding the choice of sedation agent during EVT. Clinical application of these findings is currently not possible until the trial is completed and results are published.

How this fits prior evidence

How this fits prior evidence: This protocol addresses a gap in evidence regarding sedation agents specifically for conscious sedation during endovascular thrombectomy in acute ischemic stroke. It relates to prior coverage of dexmedetomidine, which was previously reported to reduce anxiety scores in adult perioperative patients within 24 hours postoperatively. It also relates to midazolam, which was previously used in combination with ketamine to reduce intraprocedural pain.

When a person suffers a major stroke, every second counts. Doctors often use procedures like endovascular thrombectomy to clear blockages in the brain. During these intense procedures, patients need to stay calm and comfortable. This is where sedation comes in. The goal is to keep the patient still and relaxed while the medical team works to restore blood flow.

Researchers are preparing a large study to see which medication works best for this specific purpose. They will compare dexmedetomidine to midazolam, a common sedative. The study will involve up to 810 patients across 30 centers in China who have suffered a specific type of large vessel blockage. They want to see which drug helps more patients achieve a good recovery score three months after the procedure.

Because this is currently a protocol, the actual results are not available yet. The study is designed to help doctors choose the safest and most effective way to keep patients comfortable during life-saving surgery. Once the data is collected, it could help shape how doctors manage sedation for stroke patients in the future.

What this means for you:
A new trial will compare two different sedative drugs to see which is better for patients during stroke surgery.

Common questions

What drugs are being compared in this study?

The study compares dexmedetomidine to midazolam. Both are used to provide conscious sedation for patients undergoing endovascular thrombectomy, which is a procedure to treat a large blood vessel blockage caused by a stroke.

Who is eligible for this trial?

The trial is designed for patients with an acute ischemic stroke caused by a large vessel occlusion in the anterior circulation. These patients must be within 24 hours of their last known well time to be included in the study.

Are the results of this study available yet?

No, the results are not available yet. This is currently a protocol, which means it is the plan for a study that will involve up to 810 patients across 30 centers in China.

Study Details

Study typeRct
Sample sizen = 810
EvidenceLevel 2
PublishedOct 2026
View Original Abstract ↓
Background: Dexmedetomidine (DEX) and midazolam (MDZ) are commonly used agents for conscious sedation in patients with acute ischemic stroke (AIS) treated with endovascular thrombectomy (EVT). While DEX offers superior sedation quality and potential neuroprotective effects, it is also associated with risk of hemodynamic instability. High-quality evidence directly comparing their impact on functional outcomes after EVT is lacking. This trial aims to determine whether conscious sedation with DEX, compared to MDZ, improves functional outcomes in patients with AIS due to anterior circulation large vessel occlusion (LVO) undergoing EVT. Methods: PEACE (Dexmedetomidine versus Midazolam for Conscious Sedation during Endovascular Stroke Thrombectomy) is a prospective, randomized, open label, blinded-endpoint, multicenter trial. Up to 810 patients with AIS due to LVO in the anterior circulation within 24 hours of last known well will be randomly assigned in a 1:1 ratio to receive either DEX or MDZ for conscious sedation during EVT across 30 centers in China. Results: The primary end point is the proportion of patients achieving a modified Rankin Scale (mRS) score 0-2 at 90 days, analyzed in the intention-to-treat population using a modified Poisson regression model, with results expressed as a risk ratio. Key secondary outcomes include the ordinal distribution of mRS scores at 90 days, and successful recanalization. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours, and mortality at 90 days. Conclusion: The PEACE trial will provide definitive, high-level evidence on the comparative efficacy and safety of DEX versus MDZ for conscious sedation during EVT in patients with AIS due to LVO in the anterior circulation, with the goal of guiding clinical practice.
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