Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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 criteria

Qualifiers

Age ≥18 years

Acute ischemic stroke with an occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery (M1-M2) with or without association of extracranial occlusion of the cervical internal carotid artery (tandem lesion)

Eligible for mechanical thrombectomy according to international guidelines

Informed and signed consent of patient, or if he is unable to consent the consent of patient's relative or emergency procedure in the absence of relative

Disqualifiers

Coma or altered vigilance defined as a score ≥ 2 on the level of consciousness 1A subscale of the NIHSS

Premorbid disability defined as a mRS > 2

Posterior circulation stroke

Associated cerebral hemorrhage

Trial design

Treatments tested in this trial

  • General Anesthesia
  • Procedural sedation

Treatment groups

958 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Clermont-Ferrand

Lead sponsor

PHRC, Ministry of Health France

Collaborator

STROKELINK

Collaborator

ANARLF Network

Collaborator