General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke (GASS)
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ClinicalTrials.gov Identifier: NCT02822144 |
Recruitment Status :
Completed
First Posted : July 4, 2016
Last Update Posted : August 18, 2020
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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 |
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Stroke | Drug: Etomidate Drug: Succinylcholine Drug: Propofol Drug: Remifentanil Drug: Lidocaine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 351 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 |
Actual Primary Completion Date : | August 2020 |
Actual Study Completion Date : | August 2020 |
Arm | Intervention/treatment |
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Experimental: general anesthesia
General anesthesia with etomidate, succinylcholine, propofol and remifentanil
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Drug: Etomidate Drug: Succinylcholine Drug: Propofol Drug: Remifentanil |
Experimental: sedation
Sedation with remifentanil and local anesthesia with lidocaine
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Drug: Remifentanil Drug: Lidocaine |
- Score on the modified Rankin scale [ Time Frame: 3 months ]
- Recanalization delay [ Time Frame: Day 1 ]Delay between first symptoms and last angiography
- Delay between patient's hospitalization and start of procedure [ Time Frame: Day 1 ]At the time of puncture
- Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score [ Time Frame: Day 1 ]At the last angiography
- NIHSS score [ Time Frame: Day 1 ]
- NIHSS score [ Time Frame: Day 7 ]
- Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory [ Time Frame: Day 1 ]
- Mortality [ Time Frame: 3 months ]
- Number of episodes of hypo- / hypertension [ Time Frame: 24 hours after thrombectomy ]
- Number of patients with noradrenaline administration during anesthesia [ Time Frame: Day 1 ]
- 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 |
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.

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
France | |
Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest | |
Brest, France, 29609 | |
Service d'anesthésie-réanimation - Fondation A. de Rothschild | |
Paris, France, 75019 | |
Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes | |
Rennes, France, 35033 | |
Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours | |
Tours, France, 37011 |
Principal Investigator: | Axelle MAURICE, MD | Rennes University Hospital |
Responsible Party: | Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT02822144 |
Other Study ID Numbers: |
35RC15_8957 2016-000795-25 ( EudraCT Number ) |
First Posted: | July 4, 2016 Key Record Dates |
Last Update Posted: | August 18, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
ischemic stroke thrombectomy anesthesia sedation |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Lidocaine Remifentanil Propofol Etomidate Succinylcholine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs 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 |