Tests prolonged sedation with dexmedetomidine after clot removal for stroke
Tests dexmedetomidine sedation after clot removal in adults with acute ischemic stroke.
Key facts
- Who runs it
- Beijing Chao Yang Hospital
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 368 people, planned
- Started
- 1 Mar 2024
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Dexmedetomidine prolonged sedation
- 0.9% saline
- Record updated
- 20 December 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with an acute ischemic stroke who plan to have a clot-removal procedure (thrombectomy) under local anesthesia and sedation, and whose blocked vessel was successfully reopened.
- Age
- 18 Years to 80 Years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with an NIHSS score from 2 to 25. Blood flow restored after the procedure (mTICI 2b or 3). The mRS score before the stroke was less than 3.
- Earlier treatment
- Cannot have had a stent placed in the responsible vessel in the past.
Main reasons for not taking part
- Brain bleeding in the responsible vessel area in the past 6 weeks
- Pregnant or breastfeeding women
- Previous history of mental illness
- Severe liver or kidney problems
- Heart rate less than 50bpm, or systolic blood pressure less than 90mmHg
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients who had received stent treatment at the responsible vessel in the past
- Previous history of mental 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 )
- 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
- Neurological function was restored at or before angiography
- Pregnant or lactating women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Beijing ChaoYang HospitalBeijing, ChinaContact: Lina YangTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intervention groupTreatment being tested
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: Dexmedetomidine prolonged sedation
- Control groupPlacebo, for comparison
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: 0.9% saline
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)
- Plain-language title
- Tests prolonged sedation with dexmedetomidine after clot removal for strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04916197, who can take part
- Record updated
- 20 December 2023