Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine prolonged sedation, 0.9% saline.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Detailed description
Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.
Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.
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.
Interventions
- Drug Dexmedetomidine prolonged sedation
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU. - Drug 0.9% saline
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.
Primary outcome measures
- The favorable functional outcome of stroke-related disability rate [Time frame: 90 ± 14 days after thrombectomy]
Secondary outcome measures (7)
- Changes of National Institute of Health stroke scale [Time frame: 24 ± 6 hours after thrombectomy]
- Changes of National Institute of Health stroke scale [Time frame: on the 7-day or discharged day whichever comes first, up to 30 days]
- Changes of ischemic penumbra [Time frame: on the 7-day or discharged day whichever comes first, up to 30 days]
- Length of ICU stay [Time frame: From the date of admission until discharged from ICU, up to 30 days]
- Length of hospital stay [Time frame: From the date of admission until discharged from hospital, up to 30 days]
- adverse events at 90-day after operation [Time frame: within 90-day after thrombectomy]
- mortality rate at 90-day after operation [Time frame: within 90-day 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 )
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing ChaoYang Hospital — Beijing
Publications
- Yang LN, Sun Y, Wang YZ, Wang J, Qi YS, Mu SS, Liu YP, Zhang ZQ, Chen ZM, Wang XJ, Xie WX, Wei CW, Wang Y, Wu AS. Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial. Trials. 2024 Mar 4;25(1):166. doi: 10.118 PMID 38439027
Identifiers
NCT: NCT04916197 · 00375929