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

Acute Ischemic Stroke Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916197
• Other study ID #: 00375929
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Beijing Chao Yang Hospital
• Contact: Lina Yang
• Phone: 18611635556
• Email: Thoth_safin[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

Drug:
• Dexmedetomidine prolonged sedation
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
• 0.9% saline
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.

Locations

Country	Name	City	State
China	Beijing ChaoYang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 ± 14 days after thrombectomy
Secondary	Changes of National Institute of Health stroke scale	NIHSS (admission) - NIHSS (24h)	24 ± 6 hours after thrombectomy
Secondary	Changes of National Institute of Health stroke scale	NIHSS (admission) - NIHSS (7day)	on the 7-day or discharged day whichever comes first, up to 30 days
Secondary	Changes of ischemic penumbra	The difference of infarct volume between preoperative and 7-day or discharged day	on the 7-day or discharged day whichever comes first, up to 30 days
Secondary	Length of ICU stay	Length of ICU stay	From the date of admission until discharged from ICU, up to 30 days
Secondary	Length of hospital stay	Length of hospital stay	From the date of admission until discharged from hospital, up to 30 days
Secondary	adverse events at 90-day after operation	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	within 90-day after thrombectomy
Secondary	mortality rate at 90-day after operation	Death after thrombectomy within 90-day after operation	within 90-day after thrombectomy