Clinical trial NCT03229148: Anesthesia Management in Endovascular Therapy for Ischemic Stroke
Official title: Anesthesia Management in Endovascular Therapy for Ischemic Stroke: A Multicenter Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Thrombectomy
Anesthesia
Conscious Sedation
Keywords: Anesthesia or Conscious sedation for Thrombectomy for Stroke
Thrombectomy
Anesthesia
Conscious sedation
Stroke
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2017-07-25
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentic, prospective, open, in parallel groups, stratified and randomised study.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute anterior circulation ischemic stroke (terminal portion of the internal carotid artery, middle cerebral artery), with indication for radiological mechanical thrombectomy assessed by the neurology / neuroradiology team
* Over 18 years of age
* Benefiting from an affiliation to the French Social Security system
* Patient or familly informed consent. In case of patient incapacity and no family present, and due to the emergency of the procedure, the patient may be included on the sole decision of the investigator (emergency procedure with subsequent differed consent).

Exclusion Criteria:

* Altered vigilance defined by score ≥ 2 at item 1a "level of consciousness" of the NIHSS score
* Altered previous autonomy, defined by a modified Rankin score (mRS)\> 1
* Acute ischemic stroke of posterior circulation or anterior cerebral artery
* Associated brain haemorrhage
* Pregnant or nursing women
* Patient under law protection
* Stroke complicating another acute illness or postoperative stroke.

Primary outcomes:
measure: composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS
timeFrame: Day 90
Secondary outcomes:
measure: Ordinal score on the mRS by day 90
timeFrame: at day 90
measure: Functional independence by day 90 defined as a mRS score 0-2
timeFrame: at day 90
measure: Excellent recovery by day 90 defined as a mRS score 0-1
timeFrame: at day 90
measure: Moderate recovery by day 90 defined as a mRS score 0-3
timeFrame: at day 90
measure: Shift analysis of day 90 mRS adjusted for initial prognostic factors
timeFrame: at day 90
measure: Good recovery defined with sliding dichotomy responder analysis relating day 90 mRS with baseline NIHSS score: mRS 0 for NIHSS ≤ 7; mRS 0-1 for NIHSS 8-14; mRS 0-2 for NIHSS > 14
timeFrame: at day 90
measure: Intraprocedural hemodynamic and ventilatory conditions and complications defined as hypotension, blood pressure variability, hypoxemia and aspiration
timeFrame: at day 90
measure: Intervention-associated vessel and others complications defined as arterial dissection or perforation, groin hematoma, embolization in another arterial territory
timeFrame: at day 90
measure: Door to groin puncture delay
timeFrame: at day 90
measure: Door to reperfusion delay
timeFrame: at day 90
measure: Successful reperfusion defined by the modified Treatment In Cerebral Ischemia (mTICI) reperfusion scale of 2b or 3 (with a grade of 2b or 3 indicating reperfusion of > 50% of the affected territory)
timeFrame: at day 90
measure: NIHSS by day 1 and day 7
timeFrame: by day 1 and day 7
measure: Stroke unit and hospital length of stay
timeFrame: at day 90
measure: Medical complications by day 7 defined as pneumonia, acute cardiogenic pulmonary oedema, myocardial infarction, extra pulmonary infection, venous thromboembolism, new event of AIS, epilepsy, gastrointestinal bleeding or other symptomatic bleeding
timeFrame: at day 7
measure: Malignant stroke evolution by day 7
timeFrame: by day 7
measure: Symptomatic intracranial haemorrhage by day 7 defined as brain haemorrhage on imaging associated with an increase of at least 4 points in the NIHSS score
timeFrame: by day 7
measure: Unexpected intensive care unit admission by day 7
timeFrame: by day 7
measure: Mortality by day 7 and day 90
timeFrame: by day 7 and day 90
measure: Procedural feasibility score estimated by the radiologist and the anaesthesiologist and patient acceptability score
timeFrame: by day 7 and day 90
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Russel Chabanne, MD
role: PRINCIPAL_INVESTIGATOR
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