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NCT Number: NCT04916197

Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing ChaoYang Hospital

Beijing, Beijing Municipality, 100020, China

Location status: Recruiting

Location contact

Lina Yang

CONTACT

[email protected]

18611635556

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

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.

Primary outcomes

  1. The favorable functional outcome of stroke-related disability rate

    Time frame: 90 ± 14 days after thrombectomy

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

Secondary outcomes

  1. Changes of National Institute of Health stroke scale

    Time frame: 24 ± 6 hours after thrombectomy

    NIHSS (admission) - NIHSS (24h)

  2. Changes of National Institute of Health stroke scale

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

    NIHSS (admission) - NIHSS (7day)

  3. Changes of ischemic penumbra

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

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

  4. Length of ICU stay

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

    Length of ICU stay

  5. Length of hospital stay

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

    Length of hospital stay

  6. adverse events at 90-day after operation

    Time frame: within 90-day after thrombectomy

    hypotension (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

  7. mortality rate at 90-day after operation

    Time frame: within 90-day after thrombectomy

    Death after thrombectomy within 90-day after operation

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Yang

CONTACT

[email protected]

18611635556

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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