Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
NCT ID: NCT04916197
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
368 participants
INTERVENTIONAL
2024-03-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
Dexmedetomidine 0.1\~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.
Dexmedetomidine prolonged sedation
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
Control group
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.
0.9% saline
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.
Interventions
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Dexmedetomidine prolonged sedation
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
0.9% saline
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 )
18 Years
80 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Responsible Party
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Changwei Wei
Deputy chief physician
Locations
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Beijing ChaoYang Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Lina Yang
Role: primary
References
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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.
Other Identifiers
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00375929
Identifier Type: -
Identifier Source: org_study_id