General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Study Overview
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Brief Summary
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In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. Several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis). The timeliness of revascularisation is an essential factor of good prognosis. This intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. The stillness of the patient is required to control the safety of the recanalization. Currently, either a general anesthesia or a sedation can be performed. Several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology. The aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. The main outcome will be the efficacy on the functional neurological prognosis at 3 months.

Official Title
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General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Etomidate
* Drug: Succinylcholine
* Drug: Propofol
* Drug: Remifentanil
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Body mass index < or equal to 35 kg/m² , Indication for thrombectomy, after multidisciplinary consultation, Proximal artery occlusion in the anterior circulation (internal carotid artery, M1, M2,...), confirmed on imaging (angioscan or angio-MRI), Written informed consent of the patient or a close / trusted person when possible, or emergency procedure, Patient affiliated to or beneficiary of an health insurance Non-inclusion Criteria: Comorbidity committing short-term prognosis, Hemodynamic instability, Pregnant woman, Contra-indication to sedation: pre-existing swallowing impairment; restless patient, not able to stay lying down; Glasgow score < 8, Contra-indication to general anesthesia, Intubated patient at inclusion, Additional intracerebral hemorrhage, Sign of occlusion in a different cerebral territory, Known contra-indication to succinylcholine: hypersensitivity, hyperkaliemia, Known contra-indication to one of the anesthesic agents, Patient participating in another clinical trial, possibly interfering with the study procedures, Patient in a known situation of deprivation of freedom, guardianship or curatorship. Exclusion criteria: Patients with deprivation of freedom will be excluded as soon as the investigator will have knowledge of the situation.

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 |
| --- | --- |
| Experimental: general anesthesia<br>General anesthesia with etomidate, succinylcholine, propofol and remifentanil | Drug: Etomidate<br> <br> Drug: Succinylcholine<br> <br> Drug: Propofol<br> <br> Drug: Remifentanil<br> <br> |
| Experimental: sedation<br>Sedation with remifentanil and local anesthesia with lidocaine | Drug: Remifentanil<br> <br> Drug: Lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the modified Rankin scale |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization delay | Delay between first symptoms and last angiography | Day 1 | 
| Delay between patient's hospitalization and start of procedure | At the time of puncture | Day 1 | 
| Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score | At the last angiography | Day 1 | 
| NIHSS score |  | Day 1 | 
| NIHSS score |  | Day 7 | 
| Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory |  | Day 1 | 
| Mortality |  | 3 months | 
| Number of episodes of hypo- / hypertension |  | 24 hours after thrombectomy | 
| Number of patients with noradrenaline administration during anesthesia |  | Day 1 | 
| Number of sedations converted to general anesthesia and reason |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, thrombectomy, anesthesia, sedation