Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

Study Overview
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Brief Summary
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Optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. We want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia

Detailed Description
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Endovascular treatment has become standard of care for many patients with acute ischemic strokes due to large vessel occlusions and is recommended by several national and international guidelines. Several studies have shown that anesthetic modality during endovascular treatment might affect the functional outcome. While much evidence has been generated for ischemic stroke of the anterior circulation, only a few studies have investigated anesthetic modalities in strokes with occlusions of the vertebrobasilar arteries. The majority of patients with vertebrobasilar occlusion strokes undergo endovascular procedure in general anesthesia and not a less burdensome sedation despite the lack of evidence for that approach. A few retrospective studies and a small single-center prospective randomized trial investigating this topic indicate that primary procedural sedation might be a feasible anesthetic approach. Here we aim to provide further high-level evidence by conducting a prospective randomized clinical trial with a PROBE (parallel-group, open-label randomized controlled with blinded endpoint evaluation) design for this research question.

Official Title
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Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

Conditions
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Stroke Thrombectomy

Intervention / Treatment
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* Procedure: General Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment Age 18 years or older, either sex National Institutes of Health Stroke Scale (NIHSS) ≥ 4 Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA) Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure) Exclusion Criteria: Intracerebral hemorrhage Coma on admission (Glasgow Coma Scale ≤ 8) Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary Intubated state before randomization Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia Group<br>Patients randomized to the GA arm are intubated after anesthetic induction. | Procedure: General Anesthesia<br>* Patients randomized to the GA arm are intubated after anesthetic induction. For this purpose, they are pre-oxygenated with an oxygen mask and non-invasive monitoring is established. After sufficient pre-oxygenation has been applied, analgesic and sedative medication are administered. If the patient is sufficiently long nil by mouth they are manually ventilated before a muscle relaxant is administered. A rapid-sequence induction is performed with administration of an opioid, sedative and muscle relaxant in rapid succession and without intermediate manual ventilation in non-nil by mouth patients. To secure the airway, an endotracheal tube is inserted into the trachea with the aid of a laryngoscope. After insertion of the endotracheal tube, its endotracheal position is confirmed with auscultation and capnography. GA maintenance therapy with opioids, sedatives and catecholamines, if needed, will then be started.<br>|
| Experimental: Procedural Sedation Group<br>After randomization into the PS arm, the need for analgesics or sedatives are evaluated clinically. | Procedure: General Anesthesia<br>* Patients randomized to the GA arm are intubated after anesthetic induction. For this purpose, they are pre-oxygenated with an oxygen mask and non-invasive monitoring is established. After sufficient pre-oxygenation has been applied, analgesic and sedative medication are administered. If the patient is sufficiently long nil by mouth they are manually ventilated before a muscle relaxant is administered. A rapid-sequence induction is performed with administration of an opioid, sedative and muscle relaxant in rapid succession and without intermediate manual ventilation in non-nil by mouth patients. To secure the airway, an endotracheal tube is inserted into the trachea with the aid of a laryngoscope. After insertion of the endotracheal tube, its endotracheal position is confirmed with auscultation and capnography. GA maintenance therapy with opioids, sedatives and catecholamines, if needed, will then be started.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome as measured by modified Ranking Scale (mRS) after admission. | 0-6; higher mean worse outcome | 90 days +/- 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission | 0-42 points; higher mean worse outcome | [NIHSS on admission - NIHSS after 24 hours] | 
| Mortality | cerebral or non-cerebral cause of death | intra-hospital until discharge up to 2 weeks [yes/no] and over the whole follow-up period up to 3 months [time to event] | 
| Postinterventional pc-ASPECTS, determined with CT or MRI post-interventional follow up scan | semi-quantitative method for grading irreversible ischemia in the vertebrobasilar system; 0-10 points; lower mean higher infarct volumes | 12-36 hours after admission | 
| Feasibility of EST | e.g. necessity of intubation, cardio-respiratory stability, loss in level of consciousness, loss of cough reflex, vomiting | duration of thrombectomy procedure in minutes | 
| Complications before/during and after EST | e.g. severe agitation, loss of level of consciousness, loss of cough reflex, vomiting, cardio-respiratory stability | duration of the whole hospital stay in days |