Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2

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.

Conditions

• Ischemic Stroke
• Anterior Cerebral Circulation
• General Anesthesia
• Procedural Sedation
• Thrombectomy

Interventions

PROCEDURE

General 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

PROCEDURE

Procedural 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.

Sponsors & Collaborators

• PHRC, Ministry of Health France

  collaborator UNKNOWN

• STROKELINK

  collaborator UNKNOWN

• ANARLF Network

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Russell CHABANNE · CHU de Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2029-03-01

Completion

2029-03-01

Countries

• France

Study Locations