NCT04916197 Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
| NCT ID | NCT04916197 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beijing Chao Yang Hospital |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 368 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 368 participants in total. It began in 2024-03-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 )
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04916197 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04916197 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04916197 currently recruiting?
Yes, NCT04916197 is actively recruiting participants. Contact the research team at Thoth_safin@sina.com for enrollment information.
Where is the NCT04916197 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04916197 clinical trial?
NCT04916197 is sponsored by Beijing Chao Yang Hospital. The trial plans to enroll 368 participants.
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