General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-29

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke

NCT03263117

Stroke

COMPLETED PHASE4

Efficacy and Safety of Metamizole Versus Placebo as Antithermic Therapy in the Acute Phase of Ischemic Stroke

NCT02184260

Stroke

TERMINATED PHASE4

Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.

NCT06472921

Acute Ischemic Stroke

COMPLETED PHASE2

Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke

NCT06768138

Stroke, Acute Ischemic

RECRUITING PHASE3

Pre-stroke Cognitive Status and Thrombolytic Therapy

NCT01713491

Brain Ischemia Adverse Effect of Thrombolytic Drugs Impaired Cognition +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

general anesthesia

General anesthesia with etomidate, succinylcholine, propofol and remifentanil

Group Type EXPERIMENTAL

Etomidate

Intervention Type DRUG

Succinylcholine

Intervention Type DRUG

Propofol

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

sedation

Sedation with remifentanil and local anesthesia with lidocaine

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etomidate

Intervention Type DRUG

Succinylcholine

Intervention Type DRUG

Propofol

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.