Investigating sedation methods for stroke treatment
Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
This study is testing whether using sedation instead of general anesthesia during stroke treatment can help patients recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Trial ID | NCT05525325 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the feasibility of using procedural sedation compared to general anesthesia for patients undergoing endovascular treatment for vertebrobasilar stroke. The study will involve a prospective randomized design with a parallel-group approach, where patients will be assigned to either sedation or general anesthesia during their procedure. The goal is to gather high-level evidence on the impact of anesthetic modality on functional outcomes in this specific patient population, which has been under-researched compared to anterior circulation strokes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute ischemic stroke in the posterior circulation and a National Institutes of Health Stroke Scale (NIHSS) score of 4 or higher.
Not a fit: Patients with intracerebral hemorrhage, severe respiratory instability, or those who are intubated prior to randomization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less burdensome sedation methods for patients undergoing endovascular treatment, potentially improving recovery outcomes.
How similar studies have performed: While some retrospective studies and a small single-center trial have suggested that procedural sedation may be feasible, this study aims to provide more robust evidence in a prospective randomized format.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment 2. Age 18 years or older, either sex 3. National Institutes of Health Stroke Scale (NIHSS) ≥ 4 4. Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA) 5. Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure) Exclusion Criteria: 1. Intracerebral hemorrhage 2. Coma on admission (Glasgow Coma Scale ≤ 8) 3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary 4. Intubated state before randomization 5. Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)
Where this trial is running
Heidelberg, Baden-Wurttemberg
- Department of Neurology, University Hospital Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Silvia Schönenberger, MD — University Hospital Heidelberg
- Study coordinator: Min Chen, MD
- Email: min.chen@med.uni-heidelberg.de
- Phone: 0049/6221/7504
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.