General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Anesthetics; Etomidate; Lidocaine; Propofol; Remifentanil; Succinylcholine

Criteria

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.