Prolonged sedation with dexmedetomidine after stroke treatment

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

This study tests if using a sedative called dexmedetomidine after stroke treatment can help patients recover better compared to a placebo.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 368 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04916197 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of prolonged sedation using dexmedetomidine following successful reperfusion in patients who have undergone endovascular thrombectomy for acute ischemic stroke. The study aims to determine whether this sedation can improve long-term clinical outcomes by reducing sympathetic nervous system activity and mitigating ischemia-reperfusion injury. Participants will receive either dexmedetomidine or a saline solution, and their recovery will be assessed using the modified Rankin Scale. The trial is designed to provide insights into optimizing postoperative care for stroke patients.

Who should consider this trial

Good fit: Ideal candidates include adults with acute ischemic stroke who have a specific range of neurological impairment and are undergoing mechanical thrombectomy.

Not a fit: Patients with recent intracerebral hemorrhage, significant prior neurological recovery, or specific contraindications to the study medications may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could lead to improved long-term recovery outcomes for patients who have suffered an acute ischemic stroke.

How similar studies have performed: While the use of dexmedetomidine in sedation has been explored, this specific approach following endovascular thrombectomy is novel and has not been extensively tested in prior studies.

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 )

Where this trial is running

Beijing, Beijing Municipality

• Beijing ChaoYang Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lina Yang

Conditions: Acute Ischemic Stroke, Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale