Stroke
Conditions
Keywords
ischemic stroke, thrombectomy, anesthesia, sedation
Brief summary
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.
Interventions
DRUGEtomidate
DRUGSuccinylcholine
DRUGPropofol
DRUGRemifentanil
DRUGLidocaine
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on the modified Rankin scale | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score | Day 1 | At the last angiography |
| NIHSS score | Day 1 | — |
| Recanalization delay | Day 1 | Delay between first symptoms and last angiography |
| Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory | Day 1 | — |
| Delay between patient's hospitalization and start of procedure | Day 1 | At the time of puncture |
| 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 | — |
| Mortality | 3 months | — |
Countries
France
Outcome results
None listed