RecruitingNot ApplicableNCT07235514

Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2

General Anesthesia Versus Procedural Sedation in Endovascular Therapy for Anterior Circulation Large Vessel Occlusion Stroke: A Multicenter Prospective Randomized Trial


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

958 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel. The main question it aims to answer is: • Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke? GA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased. Researchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke. Participants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called General Anesthesia and a procedure called Procedural sedation for people with anterior cerebral circulation, general anesthesia, and other related conditions. The study is currently recruiting participants at 16 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGeneral Anesthesia

In the general anesthesia (GA) group with tracheal intubation : Clinical target: unarousable state Standard preoxygenation, • Rapid sequence induction of GA will use intravenous Etomidate (0.2-0.3mg/Kg) or Ketamine (1-2mg/Kg) and Succinylcholine (1mg/Kg) or Rocuronium (1.2 mg/Kg) • Maintenance of GA will use intravenous Propofol (brain tissue target controlled infusion up to 4.0 µg/mL or up to 5.0 mg/kg/hr) or Sevoflurane (end-tidal concentration up to 2% (EtSevo)) and intravenous Remifentanil (brain tissue target controlled infusion up to 4.0 ng/mL) Movement despite unarousable state: NMBA as needed

PROCEDUREProcedural sedation

In the procedural sedation group with spontaneous ventilation : Clinical target: alert and "confortable" i.e. minimal to moderate sedation level * Subcutaneous local anesthesia with Lidocaine 10mg/mL (maximum 10mL) * Intravenous Remifentanil as necessary to achieve the sedation clinical target (brain tissue target controlled infusion up to 2.0 ng/mL). Propofol could be added as necessary (brain tissue target controlled infusion up to 3.0 µg/mL or 2.0 mg/kg/hr). The lightest sedation level allowing the intervention has to be sought.


Locations(16)

Le Centre Hospitalier Universitaire d'Angers

Angers, France

Le Centre Hospitalier Universitaire Morvan de Brest de Brest

Brest, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Le centre hospitalier universitaire de Lille

Lille, France

Les Hospices Civils de Lyon

Lyon, France

L'Assistance Publique - Hôpitaux de Marseille

Marseille, France

Le centre hospitalier universitaire de Montpellier

Montpellier, France

Le Centre Hospitalier Universitaire de Nantes

Nantes, France

L'Assistance Publique - Hôpitaux de Paris

Paris, France

Le Centre Hospitalier Universitaire de La Réunion

Saint-Denis, France

Le Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, France

Le Centre Hospitalier Universitaire de Strasbourg

Strasbourg, France

L'hôpital Foch

Suresnes, France

Le Centre Hospitalier Universitaire de Bordeaux

Talence, France

Le Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Le Centre Hospitalier Universitaire de Tours

Tours, France

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NCT07235514


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