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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
351
Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest
Brest, France
Service d'anesthésie-réanimation - Fondation A. de Rothschild
Paris, France
Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes
Rennes, France
Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours
Tours, France
Score on the modified Rankin scale
Time frame: 3 months
Recanalization delay
Delay between first symptoms and last angiography
Time frame: Day 1
Delay between patient's hospitalization and start of procedure
At the time of puncture
Time frame: Day 1
Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score
At the last angiography
Time frame: Day 1
NIHSS score
Time frame: Day 1
NIHSS score
Time frame: Day 7
Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory
Time frame: Day 1
Mortality
Time frame: 3 months
Number of episodes of hypo- / hypertension
Time frame: 24 hours after thrombectomy
Number of patients with noradrenaline administration during anesthesia
Time frame: Day 1
Number of sedations converted to general anesthesia and reason
Time frame: Day 1
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