General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke (GASS)

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Stroke

Treatments: Drug: Etomidate; Drug: Remifentanil; Drug: Lidocaine; Drug: Succinylcholine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02822144

2016-000795-25 (EudraCT Number)

35RC15_8957

Details and patient eligibility

About

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.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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351 participants in 2 patient groups

general anesthesia

Experimental group

Description:

General anesthesia with etomidate, succinylcholine, propofol and remifentanil

Treatment:

Drug: Succinylcholine

Drug: Remifentanil

Drug: Propofol

Drug: Etomidate

sedation

Experimental group

Description:

Sedation with remifentanil and local anesthesia with lidocaine

Treatment:

Drug: Lidocaine

Drug: Remifentanil