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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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