General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke (GASS)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: Lidocaine; Drug: Propofol; Drug: Remifentanil; Drug: Etomidate; Drug: Succinylcholine

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest
  • Paris, France, 75019
    • Service d'anesthésie-réanimation - Fondation A. de Rothschild
  • Rennes, France, 35033
    • Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes
  • Tours, France, 37011
    • Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: general anesthesia; General anesthesia with etomidate, succinylcholine, propofol and remifentanil	Drug: Propofol; Drug: Remifentanil; Drug: Etomidate; Drug: Succinylcholine
Experimental: sedation; Sedation with remifentanil and local anesthesia with lidocaine	Drug: Lidocaine; Drug: Remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score on the modified Rankin scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		3 months
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	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
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Axelle MAURICE, MD, Rennes University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2016
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: anesthesia; ischemic stroke; sedation; thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Remifentanil; Propofol; Lidocaine; Etomidate; Succinylcholine
• Other Study ID Numbers: 35RC15_8957; 2016-000795-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO