Stroke Clinical Trial
Official title:
Anesthesia Management in Endovascular Therapy for Ischemic Stroke: A Multicenter Randomised Study
Objective of the study: to assess whether pharmacological sedation or general anesthesia for treatment of anterior circulation ischemic stroke with endovascular mechanical thrombectomy is associated with difference in morbidity (neurological outcome and peri-procedural complications).
Since 2015, the management of anterior acute ischemic stroke (AIS) involves endovascular
treatment with mechanical thrombectomy (MT). This urgent, difficult and uncomfortable
procedure in frail patients requires multidisciplinary care ideally involving neurologists,
interventional neuroradiologists and anesthesiologists.
Two anesthetic strategies are currently used: pharmacologic sedation in spontaneous
ventilation or general anesthesia with tracheal intubation. General anesthesia provides
strict immobility, protects the airway and avoids emergency intubation in case of severe
procedural complication (notably vomiting and aspiration). Sedation is a frequently used
alternative because of (1) a rapid execution which could reduce delay to reperfusion, (2) a
lower risk of blood pressure drop that may compromise cerebral blood flow in the penumbra
area, (3) the theoretical capacity to assess neurological status during the procedure and (4)
the supposed risk of complications associated with mechanical ventilation and intravenous
anesthestics on brain metabolism. Nevertheless, sedation exposes to dramatic complications in
case of patient agitation and movements.
The choice of the ideal anesthesic management is still lacking. Old retrospective studies
seemed to favor sedation with worst neurological outcome associated with general anesthesia.
Nevertheless, these datas suffered methodological issues with selection bias: more severe
patients based on NIHSS score were rather treated with general anesthesia and blood pressure
was not controlled. Recent studies that demonstrated the benefit of MT did not include a
specific anesthetic protocol and none of the studies currently available included a blood
pressure management protocol that appears to be an essential component of cerebral perfusion.
A subgroup analysis of the MR Clean study, including patients with an identical initial NIHSS
score, did not find benefit from MT in patients with general anesthesia compared to those
receiving sedation. Finally, authors concluded that performing a MT under general anesthesia
would significantly lengthen the reperfusion delay and nullify the benefit of MT.
The prospective, randomized, single-center SIESTA trial, conducted in 150 patients with an
anterior circulation AIS, found no difference in the early neurological improvement (primary
endpoint), assessed on the change in NIHSS score between admission and the 24th hour, between
the conscious sedation group and the general anesthesia group. There were a tendency for a
better 3-month neurological outcome in the general anesthesia group (37% vs 18% of patients
with a Modified Rankin score of 0-2 in the general anesthesia and conscious sedation groups
respectively), but it was not possible to conclude due to a lack of statistical power.
Due to the increasing number of patients eligible for endovascular MT and the potential
implication of these two anesthetic management on the functional outcome, a study comparing
general anesthesia and sedation during a MT seems essential as specified in the recent
updated American Stroke Association guidelines.
The objective of this study is to assess whether sedation or general anesthesia during
endovascular treatment with mechanical thrombectomy is associated with a difference in
morbidity (neurological outcome and peri-procedural complications), in anterior circulation
AIS.
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