General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

NCT02822144 | Completed Phase 3 DMC

• 2 other identifiers: 35RC15_89572016-000795-25
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke

Keywords

ischemic stroke; thrombectomy; anesthesia; sedation

Outcome Measures

Primary Outcomes (1)

• Score on the modified Rankin scale

  3 months

Secondary Outcomes (10)

• Recanalization delay

  Day 1

• Delay between patient's hospitalization and start of procedure

  Day 1

• Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score

  Day 1

• NIHSS score

  Day 1

• NIHSS score

  Day 7

Study Arms (2)

general anesthesia

EXPERIMENTAL

General anesthesia with etomidate, succinylcholine, propofol and remifentanil

Drug: Etomidate; Drug: Succinylcholine; Drug: Propofol; Drug: Remifentanil

sedation

EXPERIMENTAL

Sedation with remifentanil and local anesthesia with lidocaine

Drug: Remifentanil; Drug: Lidocaine

Interventions

Etomidate DRUG

general anesthesia

Succinylcholine DRUG

general anesthesia

Propofol DRUG

general anesthesia

Remifentanil DRUG

general anesthesia; sedation

Lidocaine DRUG

sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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,
• 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,

You may not qualify if:

• Patients with deprivation of freedom will be excluded as soon as the investigator will have knowledge of the situation.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (4)

Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest

Brest, 29609, France

Location

Service d'anesthésie-réanimation - Fondation A. de Rothschild

Paris, 75019, France

Location

Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes

Rennes, 35033, France

Location

Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours

Tours, 37011, France

Location

Related Publications (3)

• 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.

  PMID: 35226737 RESULT

• 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.

  PMID: 35857365 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.

  PMID: 31154292 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Etomidate; Succinylcholine; Propofol; Remifentanil; Lidocaine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propionates; Piperidines; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Axelle MAURICE, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 4, 2016
• Study Start: September 29, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)