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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine prolonged sedation | Drug | Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Yang | Contact | 18611635556 | Thoth_safin@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing ChaoYang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439027 | Derived | Yang LN, Sun Y, Wang YZ, Wang J, Qi YS, Mu SS, Liu YP, Zhang ZQ, Chen ZM, Wang XJ, Xie WX, Wei CW, Wang Y, Wu AS. Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial. Trials. 2024 Mar 4;25(1):166. doi: 10.1186/s13063-024-08015-x. |
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The study protocol and Informed Consent Form will be shared with other researchers.
The information will become available after the publishing of this study and will be available for 1-year after publishing.
Please contact by E-mail at thoth_safin@sina.com
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| 0.9% saline | Drug | An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU. |
|
| 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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