Clinical trial NCT04916197: Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Keywords: Endovascular thrombectomy
Dexmedetomidine
Modified Rankin Scale
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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 )

Primary outcomes:
measure: The favorable functional outcome of stroke-related disability rate
timeFrame: 90 ± 14 days after thrombectomy
Secondary outcomes:
measure: Changes of National Institute of Health stroke scale
timeFrame: 24 ± 6 hours after thrombectomy
measure: Changes of National Institute of Health stroke scale
timeFrame: on the 7-day or discharged day whichever comes first, up to 30 days
measure: Changes of ischemic penumbra
timeFrame: on the 7-day or discharged day whichever comes first, up to 30 days
measure: Length of ICU stay
timeFrame: From the date of admission until discharged from ICU, up to 30 days
measure: Length of hospital stay
timeFrame: From the date of admission until discharged from hospital, up to 30 days
measure: adverse events at 90-day after operation
timeFrame: within 90-day after thrombectomy
measure: mortality rate at 90-day after operation
timeFrame: within 90-day after thrombectomy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing ChaoYang Hospital
state: Beijing
Study officials:
References: