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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)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04916197
Enrollment
368
Registered
2021-06-07
Start date
2024-03-01
Completion date
2026-12-31
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale

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.

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

DRUGDexmedetomidine prolonged sedation

Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.

DRUG0.9% saline

An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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 )

Design outcomes

Primary

MeasureTime frameDescription
The favorable functional outcome of stroke-related disability rate90 ± 14 days after thrombectomyModified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
Changes of ischemic penumbraon the 7-day or discharged day whichever comes first, up to 30 daysThe difference of infarct volume between preoperative and 7-day or discharged day
Length of ICU stayFrom the date of admission until discharged from ICU, up to 30 daysLength of ICU stay
Changes of National Institute of Health stroke scale24 ± 6 hours after thrombectomyNIHSS (admission) - NIHSS (24h)
adverse events at 90-day after operationwithin 90-day after thrombectomyhypotension (systolic blood pressure under 90mmHg), bradycardia (heart rate under 50bpm), hypoxemia (pulse oxygen saturation under 90%), and serious events such as death and life-threatening events
mortality rate at 90-day after operationwithin 90-day after thrombectomyDeath after thrombectomy within 90-day after operation
Length of hospital stayFrom the date of admission until discharged from hospital, up to 30 daysLength of hospital stay

Countries

China

Contacts

Primary ContactLina Yang
Thoth_safin@sina.com18611635556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026