Effect of Prolonged Sedation With Dexmedetomidine on Long-term Prognosis of Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04916197

Collaborator

(none)

380

Enrollment

Location

Arms

Anticipated Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dexmedetomidine can attenuate the activity of sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Dexmedetomidine prolonged group Drug: Placebo group	Phase 4

Detailed Description

Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.

Dexmedetomidine is a commonly used sedative in mechanical thrombectomy of acute ischemic stroke.

Dexmedetomidine can attenuate the activity of sympathetic nervous system under stress response and improve ischemia-reperfusion injury.

The investigators hypothesized that the prolonged sedation of dexmedetomidine after thrombectomy may improve the clinical outcome of acute ischemic stroke patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Prolonged Sedation With Dexmedetomidine on Long-term Prognosis of Patients With Acute Ischemic Stroke After Mechanical Thrombectomy: a Single Center, Prospective, Randomized, Controlled Clinical Trial

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine prolonged group Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished mechanical thrombectomy and returned to ICU. Maintain Ramsay score 2-3.	Drug: Dexmedetomidine prolonged group Dexmedetomidine for 24h after patients finished mechanical thrombectomy and returned to ICU.
Placebo Comparator: placebo group Placebo（Equal dose of saline）24h after patients finished mechanical thrombectomy and returned to ICU. If Ramsay Sedation score was 1, midazolam was given 0.02 ~ 0.1mg/kg. If the dose of midazolam was more than 0.2mg/kg within 1 hour after operation, the Ramsay Sedation score was still 1, propofol was given to maintain sedation.	Drug: Placebo group Placebo（Equal dose of saline）24h after patients finished mechanical thrombectomy and returned to ICU.

Arm

Intervention/Treatment

Experimental: Dexmedetomidine prolonged group

Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished mechanical thrombectomy and returned to ICU. Maintain Ramsay score 2-3.

Drug: Dexmedetomidine prolonged group

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

Placebo Comparator: placebo group

Placebo（Equal dose of saline）24h after patients finished mechanical thrombectomy and returned to ICU. If Ramsay Sedation score was 1, midazolam was given 0.02 ~ 0.1mg/kg. If the dose of midazolam was more than 0.2mg/kg within 1 hour after operation, the Ramsay Sedation score was still 1, propofol was given to maintain sedation.

Drug: Placebo group

Placebo（Equal dose of saline）24h after patients finished mechanical thrombectomy and returned to ICU.

Outcome Measures

Primary Outcome Measures

The favorable functional outcome of stroke-related disability rate [90 days after operation]
Modified Rankin Scale ≤ 2 points. mRS range from 0 to 5, higher scores mean a worse outcome.

Secondary Outcome Measures

Changes of National Institute of Health stroke scale [24 hours after operation]
NIHSS admission - NIHSS 24 hours. Higher scores mean a better outcome.
Changes of National Institute of Health stroke scale [on the 7th day after surgery or discharged day, up to 30 days]
NIHSS admission - NIHSS 7th day or discharged day.Higher scores mean a better outcome.
Changes of ischemic penumbra [on the 7th day after surgery or discharged day, up to 30 days]
The difference of infarct volume between preoperative and 7th day or discharged day
Length of ICU stay [From the date of admission until discharged from ICU, up to 30 days]
Length of ICU stay
Length of hospital stay [From the date of admission until discharged from hospital, up to 30 days]
Length of hospital stay
adverse events at 90 days after operation [within 90 days 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
mortality rate at 90 days after operation [within 90 days after operation]
Death after mechanical thrombectomy within 90 days after operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 )