Acute Ischemic StrokePhase 4PEACENCT06139692
Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Acute Ischemic Stroke, run by Jinling Hospital, China at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 4 sitesChina
- Study dates
- 21 Nov 2023to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
- Long-term use of sedative medications, α2-adrenergic receptor agonists (such as clonidine), or potent CYP450 inhibitors or inducers before randomization;
- Uncontrolled hypertension or hypotension (defined as systolic blood pressure > 185 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg) measured prior to randomization;
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- 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*10^9/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 ≤ 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;
- Participation in other interventional randomized clinical trials.
- Imaging exclusion criteria
- Evidence of intracranial hemorrhage on computed tomography (CT) or magnetic resonance imaging (MRI);
- Cerebellar infarction with obvious space-occupying effects and fourth ventricle compression on CT or MRI;
- Any untreated or incompletely treated intracranial aneurysm or any intracranial vascular malformation;
- Bilateral occlusion or multiple intracranial vessels occlusions;
- Intracranial tumors (with mass effect).
Trial locations and contacts
4 sites in 1 country.
China4 sites
The General Hospital of Western Theater Command PLA
Chengdu
Liaocheng Third hsopital
Liaocheng, Shandong
Jinling Hospital, Medical School of Nanjing University
Nanjing, None Selected
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241001
About this study
Official title: Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) A Randomised Multicentre Trial
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.
Read the detailed description
In the perioperative period of endovascular thrombectomy, the main sedation options are midazolam (MDZ) and dexmedetomidine (DEX). Research has shown that both sedation methods have their advantages and disadvantages, and there is no consensus on how to choose between them. Therefore, 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 (EVT) in AIS patients with large vessel occlusion in the anterior circulation and hopes to contribute to the advancement of EVT in clinical practice.
In this trial, acute ischemic stroke patients with large vessel occlusion in the anterior circulation within 24 hours of symptom onset or last known well will be included. In the screening stage, participants who meet the inclusion criteria of the trial, upon completion of screening/baseline assessment and after signing the informed consent, will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the dexmedetomidine and midazolam conscious sedation groups. The primary end point is the proportion of modified Ranking score of 0-2 at 90 days.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Dexmedetomidine, Midazolam
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients receive perioperative sedation with dexmedetomidine
MidazolamDrug
Patients receive perioperative sedation with midazolam
| Study group | Role | What they receive |
|---|---|---|
| the dexmedetomidine group | Experimental | For patients allocated to the DEX group, sedation will be induced with an intravenous loading dose of 1.0 μg/kg administered over 10 minutes, prepared from a standard 8 μg/mL solution. This will be immediately followed by a continuous maintenance infusion, delivered via pump at a rate ranging from 0.2 to 0.7 μg/kg/h, with adjustments made according to the desired clinical effect. If adequate sedation cannot be achieved with DEX alone, physicians or anesthesiologists are permitted to administer rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia. Receives: Drug: Dexmedetomidine |
| the midazolam group | Active comparator | For patients allocated to the MDZ group, sedation will be initiated with an intravenous bolus of 0.05 mg/kg, drawn from a standard 1 mg/mL solution. A continuous maintenance infusion will then be started at a rate between 0.04 and 0.2 mg/kg/h, titrated to effect using an infusion pump. The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT. If MDZ does not achieve satisfactory sedation during procedure, physicians or anesthesiologists may choose rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of mRS score 0-2 at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Measured: 90 days after randomization
Secondary outcomes (8)
Shift in the distribution of mRS scores at 90 days
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
Measured: 90 days after randomization
Rates of successful recanalization
Successful recanalization is defined as mTICI≥2b. mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).
Measured: Immediately after the thrombectomy procedure is completed
Score on the ASPECTS at 24-72 hours
ASPECTS is short for Alberta Stroke Program Early CT Score (ranging from 0 to 10, with a higher score indicating a better perfusion state).
Measured: 24-72 hours after randomization
RASS score ≤ -3 during procedure
Deep sedation defined as RASS score ≤ -3. RASS is short for Richmond Agitation and Sedation Scale. RASS is a score of the degree of sedation (range from -5 to +4, higher values indicate a worse sedation state).
Measured: During operation
Changes of the GCS score at 5-7 days
GCS is short for Glasgow Coma Scale. GCS is a score of the degree of comma (range from 3 to 15, higher values indicate more severe comma).
Measured: 5-7 days after randomization
Changes of the NIHSS score at 5-7 days
NIHSS is short for National Institute of Health stroke scale. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).
Measured: 5-7 days after randomization
Barthel Index at 90 days
Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
Measured: 90 days after randomization
EQ-5D-5L at 90 days
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire is a cornerstone in health-related quality of life (HRQoL) assessment, widely adopted since its development in 2009 by the EuroQol Research Foundation. Designed to capture health status in five key dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. With 5 domians scoring from 1-5, 55555 is the worst and 11111 is the best.
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start21 Nov 2023
- Primary completion30 May 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinfeng Liu, Jinling Hospital, China
- Investigators
- Xinfeng Liu, Principal investigator, Department of Neurology, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139692
- Sponsor's protocol ID
- PEACE
- Acronym
- PEACE
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke (PEACE) A Randomised Multicentre Trial
- ClinicalTrials.gov ID
- NCT06139692
- Acronym / sponsor ID
- PEACE / PEACE
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the perioperative period of endovascular thrombectomy, the main sedation options are midazolam (MDZ) and dexmedetomidine (DEX). Research has shown that both sedation methods have their advantages and disadvantages, and there is no consensus on how to choose between them. Therefore, 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 (EVT) in AIS patients with large vessel occlusion in the anterior circulation and hopes to contribute to the advancement of EVT in clinical practice.
In this trial, acute ischemic stroke patients with large vessel occlusion in the anterior circulation within 24 hours of symptom onset or last known well will be included. In the screening stage, participants who meet the inclusion criteria of the trial, upon completion of screening/baseline assessment and after signing the informed consent, will be randomly assigned in a 1:1 ratio to one of the following two treatment groups: the dexmedetomidine and midazolam conscious sedation groups. The primary end point is the proportion of modified Ranking score of 0-2 at 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the dexmedetomidine group | Experimental | Drug: DexmedetomidineFor patients allocated to the DEX group, sedation will be induced with an intravenous loading dose of 1.0 μg/kg administered over 10 minutes, prepared from a standard 8 μg/mL solution. This will be immediately followed by a continuous maintenance infusion, delivered via pump at a rate ranging from 0.2 to 0.7 μg/kg/h, with adjustments made according to the desired clinical effect. If adequate sedation cannot be achieved with DEX alone, physicians or anesthesiologists are permitted to administer rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia. |
| the midazolam group | Active comparator | Drug: MidazolamFor patients allocated to the MDZ group, sedation will be initiated with an intravenous bolus of 0.05 mg/kg, drawn from a standard 1 mg/mL solution. A continuous maintenance infusion will then be started at a rate between 0.04 and 0.2 mg/kg/h, titrated to effect using an infusion pump. The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT. If MDZ does not achieve satisfactory sedation during procedure, physicians or anesthesiologists may choose rescue sedation agents (such as propofol) or consider transitioning the patient to general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- 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;
- Long-term use of sedative medications, α2-adrenergic receptor agonists (such as clonidine), or potent CYP450 inhibitors or inducers before randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients receive perioperative sedation with dexmedetomidine | Drug | the dexmedetomidine group |
| MidazolamPatients receive perioperative sedation with midazolam | Drug | the midazolam group |
Primary outcome
The proportion of mRS score 0-2 at 90 days
Time frame: 90 days after randomization
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
8 secondary outcomes
Shift in the distribution of mRS scores at 90 days
Time frame: 90 days after randomization
Rates of successful recanalization
Time frame: Immediately after the thrombectomy procedure is completed
Score on the ASPECTS at 24-72 hours
Time frame: 24-72 hours after randomization
RASS score ≤ -3 during procedure
Time frame: During operation
Changes of the GCS score at 5-7 days
Time frame: 5-7 days after randomization
Changes of the NIHSS score at 5-7 days
Time frame: 5-7 days after randomization
Barthel Index at 90 days
Time frame: 90 days after randomization
EQ-5D-5L at 90 days
Time frame: 90 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinfeng Liu principal investigator
Department of Neurology, Jinling Hospital, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Acute Ischemic Stroke, run by Jinling Hospital, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of mRS score 0-2 at 90 days (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.