Clinical trial NCT02822144: General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
Official title: General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: ischemic stroke
thrombectomy
anesthesia
sedation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Score on the modified Rankin scale
timeFrame: 3 months
Secondary outcomes:
measure: Recanalization delay
timeFrame: Day 1
measure: Delay between patient's hospitalization and start of procedure
timeFrame: Day 1
measure: Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score
timeFrame: Day 1
measure: NIHSS score
timeFrame: Day 1
measure: NIHSS score
timeFrame: Day 7
measure: Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory
timeFrame: Day 1
measure: Mortality
timeFrame: 3 months
measure: Number of episodes of hypo- / hypertension
timeFrame: 24 hours after thrombectomy
measure: Number of patients with noradrenaline administration during anesthesia
timeFrame: Day 1
measure: Number of sedations converted to general anesthesia and reason
timeFrame: Day 1
Other outcomes:
Locations:
city: Brest
country: France
facility: Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest
city: Paris
country: France
facility: Service d'anesthésie-réanimation - Fondation A. de Rothschild
city: Rennes
country: France
facility: Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes
city: Tours
country: France
facility: Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours
Study officials:
affiliation: Rennes University Hospital
name: Axelle MAURICE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maurice A, Eugene F, Ronziere T, Devys JM, Taylor G, Subileau A, Huet O, Gherbi H, Laffon M, Esvan M, Laviolle B, Beloeil H; GASS (General Anesthesia versus Sedation for Acute Stroke Treatment) Study Group and the French Society of Anesthesiologists (SFAR) Research Network. General Anesthesia versus Sedation, Both with Hemodynamic Control, during Intraarterial Treatment for Stroke: The GASS Randomized Trial. Anesthesiology. 2022 Apr 1;136(4):567-576. doi: 10.1097/ALN.0000000000004142.
citation: Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
citation: Maurice A, Ferre JC, Ronziere T, Devys JM, Subileau A, Laffon M, Laviolle B, Beloeil H; SFAR research network. GASS Trial study protocol: a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke. BMJ Open. 2019 Jun 1;9(5):e024249. doi: 10.1136/bmjopen-2018-024249.