Acute Ischemic Stroke Clinical Trial
— POSETOfficial title:
Effects of Post-operative Sedation on Clinical Outcomes in Patients Receiving Endovascular Thrombectomy for Acute Ischemic Stroke
Verified date | April 2023 |
Source | RenJi Hospital |
Contact | Weifeng Yu, Ph.D. |
Phone | 86-21-68383702 |
ywf808[@]yeah.net | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Studies from our lab indicated that long-term sedation is protective in mice with midbrain infarct. To assess whether post-operative sedation has protective effects on clinical outcomes in patients with ischemic stroke undergoing endovascular thrombectomy (ET), a multi-center, randomized clinical trial will be carried out (POSET study). In POSET study, patients receiving ET for acute ischemic stroke under general anesthesia will be randomly assigned to the control group (Con group) and the post-operative sedation group (POS group). Patients in the Con group will be recovered and extubated immediately after the surgery, whereas those in the POS group will be sedated with propofol and dexmedetomidine for another 6hrs before extubation. The primary endpoint is the score on the modified Rankin Scale assessed at 90±7 days after randomization. The hypothesis is that patients in the POS group will have improved clinical outcome in 3 months after surgery.
Status | Recruiting |
Enrollment | 1286 |
Est. completion date | February 28, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. are between 18 and 85 years old 2. have a clinical diagnosis of AIS due to anterior circulation large artery occlusion (including internal carotid artery or/and middle cerebral artery) 3. with a score on the National Institute of Health Stroke Scale (NIHSS) =10 before surgery 4. with a modified Rankin scale (mRS) <3 before stroke 5. have endovascular thrombectomy under GA and are confirmed to achieve successful reperfusion (mTICI 2b-3) by digital subtraction angiography (DSA) exam at the end of the operation. 6. Informed consent by the patient him-/herself or his/her legal representative Exclusion Criteria: 1. previous intracranial hemorrhage within 6 weeks 2. vascular stents implantation in the responsible blood vessel 3. Glasgow score =8 points before surgery 4. known allergy to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, stainless steel, and allergy or contraindication to contrast agent 5. contraindication to dexmedetomidine 6. known hemoglobin less than 70g/L, platelet count less than 50×109L, international normalized ratio (INR) greater than 1.5, or other uncorrectable bleeding issues 7. severe liver or kidney dysfunction, i.e. ALT or AST >3 times the upper limit of normal, or creatinine >1.5 times the upper limit of normal 8. are pregnant or breast feeding 9. have history of mental illness 10. are currently participating in another clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Renji Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital | Beijing Chao Yang Hospital, Changhai Hospital, Henan Provincial People's Hospital, Huashan Hospital, Shanghai 6th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Yangpu District Central Hospital |
China,
Simonsen CZ, Yoo AJ, Sorensen LH, Juul N, Johnsen SP, Andersen G, Rasmussen M. Effect of General Anesthesia and Conscious Sedation During Endovascular Therapy on Infarct Growth and Clinical Outcomes in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):470-477. doi: 10.1001/jamaneurol.2017.4474. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the score on the modified Rankin Scale assessed at 90±7 days after randomization | The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death. | at 90±7 days after ET surgery | |
Secondary | Change in NIHSS score between admission and 24±6 hrs post-operation (NIHSSadmission-NIHSS24h) | The NIHSS classifies neurological deficit on a scale from 0 (no deficit) to 42 (most severe deficit). | pre-operatively and at 24±6 hours after ET surgery | |
Secondary | Change in NIHSS score between admission and 5~7d post-operation (NIHSSadmission-NIHSS7d) | The NIHSS classifies neurological deficit on a scale from 0 (no deficit) to 42 (most severe deficit). | pre-operatively and at 5~7 days after ET surgery | |
Secondary | Final infarct volume determined by DWI or CTP at 5~7d post-operation or at discharge | The infarct size will be detected by DWI or CTP | at 5~7 days post-operation or at discharge | |
Secondary | The incidence of extubation delay | Extubation delay is defined as more than 1h is needed from the time all sedative medication is stopped and recovery is started to successful extubation. | at 24 hours after ET surgery | |
Secondary | The incidence of extubation failure | Extubation failure is defined as the need for ventilatory support after extubation using tracheal intubation or noninvasive ventilation within 24h after extubation. | at 24 hours after ET surgery | |
Secondary | Frequency of patients achieving functional independence, as reflected by an mRS score of 0 to 2 at 90±7d post-operation | The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death. All patients will be evaluated 90±7d post-operation and the incidence of patients score 0~2 will be calculated. | at 90±7 days after ET surgery | |
Secondary | Mortality rate within 90 days after ET surgery | the mortality rate within 90 days after ET surgery | at 90 days after ET surgery |
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