Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)

Study Overview
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Brief Summary
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Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Detailed Description
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Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion. Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke. Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Official Title
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Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Dexmedetomidine prolonged sedation
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2≤NIHSS≤25 mRS score before stroke was less than 3 Acute ischemic stroke (including anterior circulation) mTICI rate 2b or 3 According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation Informed consent was signed by patient or legal representative Exclusion Criteria: Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks Patients who had received stent treatment at the responsible vessel in the past Neurological function was restored at or before angiography Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors Blood glucose < 2.7 mmol/L or > 22.2 mmol/L Severe liver or kidney disfunction, ALT>3 times the upper limit of normal value or AST>3 times the upper limit of normal value, creatinine>1.5 times the upper limit of normal value Pregnant or lactating women Previous history of mental illness Stroke with other acute diseases or postoperative stroke of other operation Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Dexmedetomidine 0.1 1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3. | Drug: Dexmedetomidine prolonged sedation<br>* Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.<br>|
| Placebo Comparator: Control group<br>An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3. | Drug: 0.9% saline<br>* An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The favorable functional outcome of stroke-related disability rate | Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome. | 90 ± 14 days after thrombectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of National Institute of Health stroke scale | NIHSS (admission) - NIHSS (24h) | 24 ± 6 hours after thrombectomy | 
| Changes of National Institute of Health stroke scale | NIHSS (admission) - NIHSS (7day) | on the 7-day or discharged day whichever comes first, up to 30 days | 
| Changes of ischemic penumbra | The difference of infarct volume between preoperative and 7-day or discharged day | on the 7-day or discharged day whichever comes first, up to 30 days | 
| Length of ICU stay | Length of ICU stay | From the date of admission until discharged from ICU, up to 30 days | 
| Length of hospital stay | Length of hospital stay | From the date of admission until discharged from hospital, up to 30 days | 
| adverse events at 90-day after operation | hypotension (systolic blood pressure under 90mmHg), bradycardia (heart rate under 50bpm), hypoxemia (pulse oxygen saturation under 90%), and serious events such as death and life-threatening events | within 90-day after thrombectomy | 
| mortality rate at 90-day after operation | Death after thrombectomy within 90-day after operation | within 90-day after thrombectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale