Acute Ischemic Stroke
Conditions
Brief 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.
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.
Interventions
DRUGDexmedetomidine
Patients receive perioperative sedation with dexmedetomidine
DRUGMidazolam
Patients receive perioperative sedation with midazolam
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of mRS score 0-2 at 90 days | 90 days after randomization | mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of successful recanalization | Immediately after the thrombectomy procedure is completed | 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). |
| Changes of the GCS score at 24 hours | 24 hours after randomization | 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). |
| Changes of the NIHSS score at 24 hours | 24 hours after randomization | 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). |
| Changes of the GCS score at 5-7 days | 5-7 days after randomization | 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). |
| Changes of the NIHSS score at 5-7 days | 5-7 days after randomization | 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). |
| Barthel Index at 90 days | 90 days after randomization | Barthel Index is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis) |
| RASS score ≤ 0 during procedure | During operation | 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). |
| Shift in the distribution of mRS scores at 90 days | 90 days after randomization | mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome). |
| The proportion of mRS score 0-1 at 90 days | 90 days after randomization | mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome). |
| The proportion of mRS score 0-3 at 90 days | 90 days after randomization | mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome). |
| Score on the ASPECTS at 24-72 hours | 24-72 hours after randomization | ASPECTS is short for Alberta Stroke Program Early CT Score (ranging from 0 to 10, with a higher score indicating a better perfusion state). |
| RASS score ≤ -3 during procedure | During operation | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of mortality at 90 days | within 90 days from randomization | Clinical safety endpoint |
| Rates of adverse events | within 90 days from randomization | Clinical safety endpoint |
| Rates of severe adverse events | with 90 days from randomization | Clinical safety endpoint |
| Rates of symptomatic intracranial hemorrhage at 48 hours | 48 hours after randomization | Clinical safety endpoint. Intracranial hemorrhage within 48 hours on CT/MRI according to Heidelberg bleeding classification. |
| Rates of procedure-related complications | within 90 days from randomization | Clinical safety endpoint |
Countries
China
Contacts
Primary ContactRui Liu
Backup ContactXinfeng Liu
Outcome results
None listed