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

Primary Purpose

Stroke

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Etomidate

Succinylcholine

Propofol

Remifentanil

Lidocaine

About this trial

This is an interventional treatment trial for Stroke focused on measuring ischemic stroke, thrombectomy, anesthesia, sedation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest
Service d'anesthésie-réanimation - Fondation A. de Rothschild
Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes
Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

general anesthesia

sedation

Arm Description

General anesthesia with etomidate, succinylcholine, propofol and remifentanil

Sedation with remifentanil and local anesthesia with lidocaine

Outcomes

Primary Outcome Measures

Score on the modified Rankin scale

Secondary Outcome Measures

Recanalization delay

Delay between first symptoms and last angiography

Delay between patient's hospitalization and start of procedure

At the time of puncture

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

At the last angiography

NIHSS score

Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory

Mortality

Number of episodes of hypo- / hypertension

Number of patients with noradrenaline administration during anesthesia

Number of sedations converted to general anesthesia and reason

Full Information

NCT ID

NCT02822144

First Posted

June 27, 2016

Last Updated

May 19, 2023

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02822144

Brief Title

General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Acronym

GASS

Official Title

General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

September 29, 2016 (Actual)

Primary Completion Date

August 2020 (Actual)

Study Completion Date

August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

ischemic stroke, thrombectomy, anesthesia, sedation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

351 (Actual)

8. Arms, Groups, and Interventions

Arm Title

general anesthesia

Arm Type

Experimental

Arm Description

General anesthesia with etomidate, succinylcholine, propofol and remifentanil

Arm Title

sedation

Arm Type

Experimental

Arm Description

Sedation with remifentanil and local anesthesia with lidocaine

Intervention Type

Drug

Intervention Name(s)

Etomidate

Intervention Type

Drug

Intervention Name(s)

Succinylcholine

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Type

Drug

Intervention Name(s)

Remifentanil

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Primary Outcome Measure Information:

Title

Score on the modified Rankin scale

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Recanalization delay

Description

Delay between first symptoms and last angiography

Time Frame

Day 1

Title

Delay between patient's hospitalization and start of procedure

Description

At the time of puncture

Time Frame

Day 1

Title

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

Description

At the last angiography

Time Frame

Day 1

Title

NIHSS score

Time Frame

Day 1

Title

NIHSS score

Time Frame

Day 7

Title

Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory

Time Frame

Day 1

Title

Mortality

Time Frame

3 months

Title

Number of episodes of hypo- / hypertension

Time Frame

24 hours after thrombectomy

Title

Number of patients with noradrenaline administration during anesthesia

Time Frame

Day 1

Title

Number of sedations converted to general anesthesia and reason

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Axelle MAURICE, MD

Organizational Affiliation

Rennes University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

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

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

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

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

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

City

Tours

ZIP/Postal Code

37011

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35226737

Citation

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.

Results Reference

result

PubMed Identifier

35857365

Citation

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.

Results Reference

derived

PubMed Identifier

31154292

Citation

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.

Results Reference

derived

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General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

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