General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Stroke Clinical Trial

— GASS  

Official title:

General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822144
• Other study ID #: 35RC15_8957
• Secondary ID: 2016-000795-25
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2016
• Est. completion date: August 2020

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Etomidate

• Succinylcholine

• Propofol

• Remifentanil

• Lidocaine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

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