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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)

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Chao Yang Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

2≤NIHSS≤25

mRS score before stroke was less than 3

Acute ischemic stroke (including anterior circulation)

mTICI rate 2b or 3

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine prolonged sedation

    Drug

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

  • 0.9% saline

    Drug

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

Treatment groups

368 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The favorable functional outcome of stroke-related disability rate

Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.

Time frame
90 ± 14 days after thrombectomy

Secondary outcomes

1

Changes of National Institute of Health stroke scale

NIHSS (admission) - NIHSS (24h)

Time frame
24 ± 6 hours after thrombectomy
2

Changes of National Institute of Health stroke scale

NIHSS (admission) - NIHSS (7day)

Time frame
on the 7-day or discharged day whichever comes first, up to 30 days
3

Changes of ischemic penumbra

The difference of infarct volume between preoperative and 7-day or discharged day

Time frame
on the 7-day or discharged day whichever comes first, up to 30 days
4

Length of ICU stay

Length of ICU stay

Time frame
From the date of admission until discharged from ICU, up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Chao Yang Hospital

Lead sponsor

Source ClinicalTrials.gov
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