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.
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
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
Parallel
General Anesthesia
Procedure/SurgeryIn 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
Procedural sedation
Procedure/SurgeryIn 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.
modified Rankin Scale
modified Rankin Scale, that range from 0 to 6: 0, no neurologic deficit; 1, no clinically significant disability; 2, slight disability; 3, moderate disability requiring some help; 4, moderately severe disability; 5, severe disability; 6, death \> measured centrally by a blinded evaluator
Functional independence = key secondary outcome
Functional independence defined as a score of 0-2 on the rating of the modified Rankin Scale measured centrally by a blinded evaluator. This will be analyzed as a dichotomized measure
Modified Treatment in Cerebral Infarction scale at the end of thrombectomy (mTICI).
To assessed efficacy of GA vs PS
Good quality of reperfusion defined as a mTICI score of 2b-3
To assessed efficacy of GA vs PS
Excellent quality of reperfusion defined as a mTICI score of 2c-3
To assessed efficacy of GA vs PS
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University Hospital, Clermont-Ferrand
Lead sponsor
PHRC, Ministry of Health France
Collaborator
STROKELINK
Collaborator
ANARLF Network
Collaborator
