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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000795-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general anesthesia | Experimental | General anesthesia with etomidate, succinylcholine, propofol and remifentanil |
|
| sedation | Experimental | Sedation with remifentanil and local anesthesia with lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etomidate | Drug |
| ||
| Succinylcholine |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the modified Rankin scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization delay | Delay between first symptoms and last angiography | Day 1 |
| Delay between patient's hospitalization and start of procedure | At the time of puncture |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axelle MAURICE, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest | Brest | 29609 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35226737 | Result | 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. | |
| 35857365 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| D013390 | Succinylcholine |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Propofol | Drug |
|
| Remifentanil | Drug |
|
| Lidocaine | Drug |
|
| Day 1 |
| Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score | At the last angiography | Day 1 |
| NIHSS score | Day 1 |
| NIHSS score | Day 7 |
| 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 |
| Service d'anesthésie-réanimation - Fondation A. de Rothschild |
| Paris |
| 75019 |
| France |
| Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes | Rennes | 35033 | France |
| Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours | Tours | 37011 | France |
| Derived |
| 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. |
| 31154292 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002794 |
| Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009861 | Onium Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011422 | Propionates |
| D010880 | Piperidines |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |