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StrokePhase 3GASSNCT02822144

General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

A Phase 3 study testing Etomidate, Succinylcholine and Propofol in people with Stroke, run by Rennes University Hospital at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Etomidate, Succinylcholine and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
4 sitesFrance
Study dates
29 Sep 2016to Aug 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

France4 sites

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

    Brest, 29609

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

    Paris, 75019

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

    Rennes, 35033

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

    Tours, 37011

Other trials in France

About this study

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.

Read more

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
Being tested
Etomidate, Succinylcholine, Propofol, Remifentanil, Lidocaine
Keywords
ischemic stroke, thrombectomy, anesthesia, sedation
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02822144
Study groupRoleWhat they receive
general anesthesiaExperimentalGeneral anesthesia with etomidate, succinylcholine, propofol and remifentanil
Receives: Drug: Etomidate; Drug: Succinylcholine; Drug: Propofol; Drug: Remifentanil
sedationExperimentalSedation with remifentanil and local anesthesia with lidocaine
Receives: Drug: Remifentanil; Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on the modified Rankin scale

    Measured: 3 months

Secondary outcomes (10)

  1. Recanalization delay

    Delay between first symptoms and last angiography

    Measured: Day 1

  2. Delay between patient's hospitalization and start of procedure

    At the time of puncture

    Measured: Day 1

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

    At the last angiography

    Measured: Day 1

  4. NIHSS score

    Measured: Day 1

  5. NIHSS score

    Measured: Day 7

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

    Measured: Day 1

  7. Mortality

    Measured: 3 months

  8. Number of episodes of hypo- / hypertension

    Measured: 24 hours after thrombectomy

  9. Number of patients with noradrenaline administration during anesthesia

    Measured: Day 1

  10. Number of sedations converted to general anesthesia and reason

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2016 (estimated)
  2. Study start29 Sep 2016
  3. Primary completionAug 2020
  4. Study completionAug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02822144
Sponsor's protocol ID
35RC15_8957
Other IDs
2016-000795-25, 2016
Acronym
GASS
Status last verified
May 2023
First submitted
27 Jun 2016
Last updated
23 May 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35226737

  • 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.

    PubMed 35857365

  • 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.

    PubMed 31154292

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etomidate, Succinylcholine and Propofol in people with Stroke, run by Rennes University Hospital at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on the modified Rankin scale (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02822144, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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