drugset / Trial / NCT02822144

General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

NCT02822144

Phase 3 Completed 351 enrolled Rennes University Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2016-09-29
Primary completion
2020-08
Completion
2020-08

Drugs

EvaluationDrugModalityDoseRoute
Background Etomidate Small molecule
Background Lidocaine Other / unclassified
Background Propofol Small molecule
Background Remifentanil Small molecule
Background Suxamethonium Other / unclassified

Indications