Back to resultsEffect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
Primary Purpose
Acute Ischemic Stroke
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine prolonged sedation
0.9% saline
Sponsored by
About this trial
This is an interventional prevention trial for Acute Ischemic Stroke focused on measuring Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale
Eligibility Criteria
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 )
Sites / Locations
- Beijing ChaoYang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.
An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes of National Institute of Health stroke scale
NIHSS (admission) - NIHSS (24h)
Changes of National Institute of Health stroke scale
NIHSS (admission) - NIHSS (7day)
Changes of ischemic penumbra
The difference of infarct volume between preoperative and 7-day or discharged day
Length of ICU stay
Length of ICU stay
Length of hospital stay
Length of hospital stay
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
mortality rate at 90-day after operation
Death after thrombectomy within 90-day after operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04916197
Brief Title
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Endovascular thrombectomy, Dexmedetomidine, Modified Rankin Scale
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine prolonged sedation
Intervention Description
Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.
Primary Outcome Measure Information:
Title
The favorable functional outcome of stroke-related disability rate
Description
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 Outcome Measure Information:
Title
Changes of National Institute of Health stroke scale
Description
NIHSS (admission) - NIHSS (24h)
Time Frame
24 ± 6 hours after thrombectomy
Title
Changes of National Institute of Health stroke scale
Description
NIHSS (admission) - NIHSS (7day)
Time Frame
on the 7-day or discharged day whichever comes first, up to 30 days
Title
Changes of ischemic penumbra
Description
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
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
From the date of admission until discharged from ICU, up to 30 days
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
From the date of admission until discharged from hospital, up to 30 days
Title
adverse events at 90-day after operation
Description
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
Time Frame
within 90-day after thrombectomy
Title
mortality rate at 90-day after operation
Description
Death after thrombectomy within 90-day after operation
Time Frame
within 90-day after thrombectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Yang
Phone
18611635556
Email
Thoth_safin@sina.com
Facility Information:
Facility Name
Beijing ChaoYang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Yang
Phone
18611635556
Email
Thoth_safin@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol and Informed Consent Form will be shared with other researchers.
IPD Sharing Time Frame
The information will become available after the publishing of this study and will be available for 1-year after publishing.
IPD Sharing Access Criteria
Please contact by E-mail at thoth_safin@sina.com
Learn more about this trial
Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With EVT on Long-term Prognosis in Patients With AIS (PPDET)
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