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

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ClinicalTrials.gov Identifier: NCT02822144
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Stroke Drug: Etomidate Drug: Succinylcholine Drug: Propofol Drug: Remifentanil Drug: Lidocaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
Actual Study Start Date : September 29, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: general anesthesia
General anesthesia with etomidate, succinylcholine, propofol and remifentanil
Drug: Etomidate
Drug: Succinylcholine
Drug: Propofol
Drug: Remifentanil
Experimental: sedation
Sedation with remifentanil and local anesthesia with lidocaine
Drug: Remifentanil
Drug: Lidocaine



Primary Outcome Measures :
  1. Score on the modified Rankin scale [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822144


Contacts
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Contact: Claire LAFOREST, PharmD 033299289897 claire.laforest@chu-rennes.fr
Contact: Aurélie VEISLINGER, MSc 033299289752 aurelie.veislinger@chu-rennes.fr

Locations
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France
Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest Recruiting
Brest, France, 29609
Contact: Aurélie SUBILEAU, MD         
Service d'anesthésie-réanimation - Fondation A. de Rothschild Recruiting
Paris, France, 75019
Contact: Jean-Michel DEVYS, MD         
Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Axelle MAURICE, MD         
Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours Recruiting
Tours, France, 37011
Contact: Marc LAFFON, MD, PhD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Axelle MAURICE, MD Rennes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02822144     History of Changes
Other Study ID Numbers: 35RC15_8957
2016-000795-25 ( EudraCT Number )
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rennes University Hospital:
ischemic stroke
thrombectomy
anesthesia
sedation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Remifentanil
Anesthetics
Propofol
Etomidate
Succinylcholine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Neuromuscular Depolarizing Agents