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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Dexmedetomidine prolonged sedation
  Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
• Препарат 0.9% saline
  An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.

Первичные конечные точки

• The favorable functional outcome of stroke-related disability rate [Срок оценки: 90 ± 14 days after thrombectomy]

Вторичные конечные точки (7)

• Changes of National Institute of Health stroke scale [Срок оценки: 24 ± 6 hours after thrombectomy]
• Changes of National Institute of Health stroke scale [Срок оценки: on the 7-day or discharged day whichever comes first, up to 30 days]
• Changes of ischemic penumbra [Срок оценки: on the 7-day or discharged day whichever comes first, up to 30 days]
• Length of ICU stay [Срок оценки: From the date of admission until discharged from ICU, up to 30 days]
• Length of hospital stay [Срок оценки: From the date of admission until discharged from hospital, up to 30 days]
• adverse events at 90-day after operation [Срок оценки: within 90-day after thrombectomy]
• mortality rate at 90-day after operation [Срок оценки: within 90-day after thrombectomy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 )

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing ChaoYang Hospital — Пекин

Публикации

• 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: 10.118 PMID 38439027

Идентификаторы

NCT: NCT04916197 · 00375929

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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