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

Not yet recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Lidocaine Drug
    ARM 1: Kind: Experimental
    Label: sedation
    Description: Sedation with remifentanil and local anesthesia with lidocaine
  • Propofol Drug
    Other Names: Diprivan
    ARM 1: Kind: Experimental
    Label: general anesthesia
    Description: General anesthesia with etomidate, succinylcholine, propofol and remifentanil
  • Remifentanil Drug
    Other Names: Conscious sedation
    ARM 1: Kind: Experimental
    Label: general anesthesia
    Description: General anesthesia with etomidate, succinylcholine, propofol and remifentanil
    ARM 2: Kind: Experimental
    Label: sedation
    Description: Sedation with remifentanil and local anesthesia with lidocaine
  • Etomidate Drug
    Other Names: Amidate
    ARM 1: Kind: Experimental
    Label: general anesthesia
    Description: General anesthesia with etomidate, succinylcholine, propofol and remifentanil
  • Succinylcholine Drug
    ARM 1: Kind: Experimental
    Label: general anesthesia
    Description: General anesthesia with etomidate, succinylcholine, propofol and remifentanil

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Score on the modified Rankin scale 3 months No
Secondary Recanalization delay Day 1 No
Secondary Delay between patient's hospitalization and start of procedure Day 1 No
Secondary Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score Day 1 No
Secondary NIHSS score Day 1 No
Secondary Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory Day 1 Yes
Secondary Mortality 3 months Yes
Secondary Number of episodes of hypo- / hypertension 24 hours after thrombectomy Yes
Secondary Number of patients with noradrenaline administration during anesthesia Day 1 Yes
Secondary Number of sedations converted to general anesthesia and reason Day 1 Yes

Sponsors