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

Capital Medical University

Status and phase: Enrolling; Phase 4

Conditions: Acute Ischemic Stroke

Treatments: Drug: 0.9% saline; Drug: Dexmedetomidine prolonged sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT04916197

00375929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 368 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Dexmedetomidine 0.1\~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.

Treatment:

Drug: Dexmedetomidine prolonged sedation

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% saline