Clinical trial

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

Name
00375929
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Dexmedetomidine prolonged sedation
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
Arms:
Intervention group
0.9% saline
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.
Arms:
Control group
Size
368
Primary endpoint
The favorable functional outcome of stroke-related disability rate
90 ± 14 days after thrombectomy
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 )
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 368, 'type': 'ESTIMATED'}}
Updated at
2023-12-20

1 organization

1 product

1 drug

1 indication

Indication
Stroke