Stroke Clinical Trial
— GASSOfficial title:
General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 351 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest | Brest | |
France | Service d'anesthésie-réanimation - Fondation A. de Rothschild | Paris | |
France | Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes | Rennes | |
France | Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score on the modified Rankin scale | 3 months | ||
Secondary | Recanalization delay | Delay between first symptoms and last angiography | Day 1 | |
Secondary | Delay between patient's hospitalization and start of procedure | At the time of puncture | Day 1 | |
Secondary | Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score | At the last angiography | Day 1 | |
Secondary | NIHSS score | Day 1 | ||
Secondary | NIHSS score | Day 7 | ||
Secondary | Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory | Day 1 | ||
Secondary | Mortality | 3 months | ||
Secondary | Number of episodes of hypo- / hypertension | 24 hours after thrombectomy | ||
Secondary | Number of patients with noradrenaline administration during anesthesia | Day 1 | ||
Secondary | Number of sedations converted to general anesthesia and reason | Day 1 |
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