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Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

ConditionStroke Thrombectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • General Anesthesia

    Procedure/Surgery

    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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: General Anesthesia GroupActive comparator 1 intervention
Group B: Procedural Sedation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Functional outcome as measured by modified Ranking Scale (mRS) after admission.

0-6; higher mean worse outcome

Time frame
90 days +/- 2 weeks

Secondary outcomes

1

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

Time frame
[NIHSS on admission - NIHSS after 24 hours]
2

Mortality

cerebral or non-cerebral cause of death

Time frame
intra-hospital until discharge up to 2 weeks [yes/no] and over the whole follow-up period up to 3 months [time to event]
3

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

Time frame
12-36 hours after admission
4

Feasibility of EST

e.g. necessity of intubation, cardio-respiratory stability, loss in level of consciousness, loss of cough reflex, vomiting

Time frame
duration of thrombectomy procedure in minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

Source ClinicalTrials.gov
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