Post-operative sedation effects in stroke patients after thrombectomy
Effects of Post-operative Sedation on Clinical Outcomes in Patients Receiving Endovascular Thrombectomy for Acute Ischemic Stroke
This study is testing if keeping stroke patients sedated for a few hours after surgery can help them recover better compared to those who wake up right away.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1286 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04517383 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the potential protective effects of post-operative sedation on patients undergoing endovascular thrombectomy for acute ischemic stroke. Participants will be randomly assigned to either a control group, where they are extubated immediately after surgery, or a sedation group, where they will receive sedation with propofol and dexmedetomidine for an additional six hours. The primary outcome will be assessed using the modified Rankin Scale at 90 days post-surgery, aiming to determine if prolonged sedation improves clinical outcomes. The study is based on previous findings that suggest longer sedation may enhance brain protection during recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with acute ischemic stroke due to anterior circulation large artery occlusion and a moderate to severe stroke severity score.
Not a fit: Patients with recent intracranial hemorrhage, severe pre-operative Glasgow scores, or contraindications to the sedation agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes for stroke patients undergoing thrombectomy.
How similar studies have performed: While some studies have suggested benefits of general anesthesia in similar contexts, this specific approach of extended post-operative sedation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Renji Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weifeng Yu, Ph.D.
- Email: ywf808@yeah.net
- Phone: 86-21-68383702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.