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NCT Number: NCT02822144

General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etomidate

Drug

Succinylcholine

Drug

Propofol

Drug

Remifentanil

Drug

Lidocaine

Drug

Primary outcomes

  1. Score on the modified Rankin scale

    Time frame: 3 months

Secondary outcomes

  1. Recanalization delay

    Time frame: Day 1

    Delay between first symptoms and last angiography

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

    Time frame: Day 1

    At the time of puncture

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

    Time frame: Day 1

    At the last angiography

  4. NIHSS score

    Time frame: Day 1

  5. NIHSS score

    Time frame: Day 7

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

    Time frame: Day 1

  7. Mortality

    Time frame: 3 months

  8. Number of episodes of hypo- / hypertension

    Time frame: 24 hours after thrombectomy

  9. Number of patients with noradrenaline administration during anesthesia

    Time frame: Day 1

  10. Number of sedations converted to general anesthesia and reason

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: GASS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 4, 2016
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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