NCT04916197RecruitingPhase 4
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)
Source: ClinicalTrials.gov · Last updated 20 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 368 (estimated)
- First submitted
- 25 May 2021
- Start date
- 1 Mar 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Beijing Chao Yang Hospital
- Diseases
- Stroke
- NCT number
- NCT04916197
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 368
- From 1 Mar 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had received stent treatment at the responsible vessel in the past
- Previous history of mental illness
Other illness
- Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
- 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
- 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 )
Lab values
- 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
Other
- Neurological function was restored at or before angiography
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing ChaoYang Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.