Chabanne 2019.

Study name	Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol
Methods	Setting: multicentre, France Design: RCT, 2 arms, parallel assignment, open‐label single‐blind Start date: 20 July 2017 (reported in protocol) Completion date: 30 June 2020 (reported in protocol)
Participants	332 men and women aged ≥ 18 years Diagnostic criteria: AIS with LVO in anterior cerebral circulation Inclusion criteria Acute anterior circulation ischaemic stroke (terminal portion of the internal carotid artery, middle cerebral artery), with an indication for radiological mechanical thrombectomy assessed by the neurology/neuroradiology team Aged ≥ 18 years Benefiting from affiliation to the French Social Security system Participant or family informed consent. In case of participant incapacity and no family present, and due to the emergency of the procedure, the participant may be included at 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 an mRS > 1 AIS of posterior circulation or anterior cerebral artery associated brain haemorrhage Pregnant or breastfeeding Person under law protection Stroke complicating another acute illness or postoperative stroke
Interventions	Experimental: GA Comparator: CSA
Outcomes	Primary outcomes Composite of functional independence at 3 months and absence of medical complication occurring by day 7 after EVT for anterior circulation AIS (time frame: day 90) Secondary outcomes Ordinal score on the mRS by day 90 Functional independence by day 90 defined as a mRS score 0–2 Excellent recovery by day 90 defined as a mRS score 0–1 Moderate recovery by day 90 defined as a mRS score 0–3 Shift analysis of day 90 mRS adjusted for initial prognostic factors (baseline mRS, age, initial NIHSS, carotid top occlusion) 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 Intraprocedural haemodynamic and ventilatory conditions and complications defined as hypotension, blood pressure variability, hypoxaemia, and aspiration (time frame: at day 90) Intervention‐associated vessel and other complications defined as arterial dissection or perforation, groin haematoma, embolisation in another arterial territory (time frame: at day 90) Door‐to‐groin puncture delay (time frame: at day 90) Door‐to‐reperfusion delay (time frame: at day 90) Successful reperfusion defined by the mTICI reperfusion scale of 2b or 3 (with a grade of 2b or 3 indicating reperfusion of > 50% of the affected territory) (time frame: at day 90) NIHSS by day 1 and day 7 Stroke unit and hospital length of stay (time frame: at day 90) Medical complications by day 7 defined as pneumonia, acute cardiogenic pulmonary oedema, myocardial infarction, extrapulmonary infection, venous thromboembolism, new event of AIS, epilepsy, gastrointestinal bleeding, or other symptomatic bleeding (time frame: at day 7) Malignant stroke evolution by day 7 Symptomatic intracranial haemorrhage by day 7 defined as brain haemorrhage on imaging associated with an increase of ≥ 4 points in the NIHSS score Unexpected ICU admission by day 7 Mortality by day 7 and 90 Procedural feasibility score estimated by the radiologist and the anaesthesiologist and participant acceptability score (time frame: by day 7 and 90)
Starting date	20 July 2017
Contact information	Telephone number and email address not provided
Notes	NCT03229148