General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
- Conditions
- Stroke
- Interventions
- Registration Number
- NCT02822144
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. Several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis).
The timeliness of revascularisation is an essential factor of good prognosis. This intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. The stillness of the patient is required to control the safety of the recanalization. Currently, either a general anesthesia or a sedation can be performed.
Several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology.
The aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. The main outcome will be the efficacy on the functional neurological prognosis at 3 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
- Age > 18 years
- Body mass index < or equal to 35 kg/m² ,
- Indication for thrombectomy, after multidisciplinary consultation,
- Proximal artery occlusion in the anterior circulation (internal carotid artery, M1, M2,...), confirmed on imaging (angioscan or angio-MRI),
- Written informed consent of the patient or a close / trusted person when possible, or emergency procedure,
- Patient affiliated to or beneficiary of an health insurance
Non-inclusion Criteria:
- Comorbidity committing short-term prognosis,
- Hemodynamic instability,
- Pregnant woman,
- Contra-indication to sedation: pre-existing swallowing impairment; restless patient, not able to stay lying down; Glasgow score < 8,
- Contra-indication to general anesthesia,
- Intubated patient at inclusion,
- Additional intracerebral hemorrhage,
- Sign of occlusion in a different cerebral territory,
- Known contra-indication to succinylcholine: hypersensitivity, hyperkaliemia,
- Known contra-indication to one of the anesthesic agents,
- Patient participating in another clinical trial, possibly interfering with the study procedures,
- Patient in a known situation of deprivation of freedom, guardianship or curatorship.
Exclusion criteria:
- Patients with deprivation of freedom will be excluded as soon as the investigator will have knowledge of the situation.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sedation Remifentanil Sedation with remifentanil and local anesthesia with lidocaine sedation Lidocaine Sedation with remifentanil and local anesthesia with lidocaine general anesthesia Etomidate General anesthesia with etomidate, succinylcholine, propofol and remifentanil general anesthesia Succinylcholine General anesthesia with etomidate, succinylcholine, propofol and remifentanil general anesthesia Propofol General anesthesia with etomidate, succinylcholine, propofol and remifentanil general anesthesia Remifentanil General anesthesia with etomidate, succinylcholine, propofol and remifentanil
- Primary Outcome Measures
Name Time Method Score on the modified Rankin scale 3 months
- Secondary Outcome Measures
Name Time Method NIHSS score Day 7 Recanalization delay Day 1 Delay between first symptoms and last angiography
Delay between patient's hospitalization and start of procedure Day 1 At the time of puncture
Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score Day 1 At the last angiography
Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory Day 1 Mortality 3 months Number of episodes of hypo- / hypertension 24 hours after thrombectomy Number of patients with noradrenaline administration during anesthesia Day 1 Number of sedations converted to general anesthesia and reason Day 1
Trial Locations
- Locations (4)
Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes
🇫🇷Rennes, France
Service d'anesthésie-réanimation - Fondation A. de Rothschild
🇫🇷Paris, France
Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest
🇫🇷Brest, France
Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours
🇫🇷Tours, France