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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the dexmedetomidine group | Experimental | In the experimental group, dexmedetomidine is used for intraoperative sedation. Dexmedetomidine is prepared as an 8μg/ml intravenous infusion. It begins with an initial loading dose of 1μg/kg, administered over a period exceeding 10 minutes.If dexmedetomidine fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg/(kg*h) and a maintenance dose of 0.3-4mg/(kg*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT. |
|
| the midazolam group | Active Comparator | In the control group, midazolam is used for intraoperative sedation. Midazolam is prepared as a 1mg/ml intravenous infusion. It starts with an initial intravenous push of 0.05mg/kg, followed by a maintenance dose of 0.04-0.2mg/kg administered intravenously via an infusion pump. If midazolam fails to achieve a satisfactory level of sedation during surgery, physicians may opt for rescue sedation with propofol or consider transferring the patient to general anesthesia. Propofol (20ml 0.2g) starts with a loading dose of 0.3mg/(kg*h) and a maintenance dose of 0.3-4mg/(kg*h). The infusion rate can be adjusted based on the sedation effect to achieve the appropriate level of sedation during EVT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patients receive perioperative sedation with dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90 days after randomization |
| The proportion of mRS score 0-1 at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of symptomatic intracranial hemorrhage at 48 hours | Clinical safety endpoint. Intracranial hemorrhage within 48 hours on CT/MRI according to Heidelberg bleeding classification. | 48 hours after randomization |
| Rates of procedure-related complications |
Inclusion Criteria:
Exclusion Criteria:
General 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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | +86 2584801861 | liurui8616@163.com | |
| Xinfeng Liu | Contact | +86 2584801861 | xfliu2@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinfeng Liu | Department of Neurology, Jinling Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital, Medical School of Nanjing University | Recruiting | Nanjing | None Selected | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | Patients receive perioperative sedation with midazolam |
|
mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).
| 90 days after randomization |
| The proportion of mRS score 0-3 at 90 days | mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome). | 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). | 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). | 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). | During operation |
| RASS score ≤ 0 during procedure | Under sedation defined as RASS score ≤ 0. 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). | During operation |
| Changes of the GCS score at 24 hours | 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). | 24 hours after randomization |
| Changes of the NIHSS score at 24 hours | 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). | 24 hours after randomization |
| 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). | 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). | 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) | 90 days after randomization |
Clinical safety endpoint
| within 90 days from randomization |
| Rates of mortality at 90 days | Clinical safety endpoint | within 90 days from randomization |
| Rates of adverse events | Clinical safety endpoint | within 90 days from randomization |
| Rates of severe adverse events | Clinical safety endpoint | with 90 days from randomization |
| The General Hospital of Western Theater Command PLA | Recruiting | Chengdu | China |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |